Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

TITLE OF THE INVENTION
STENT DEPLOYMENT DEVICE

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
[1] The present disclosure relates to a medical device. More particularly, the present disclosure relates to a stent deployment device.
BACKGROUND OF INVENTION
[2] Stent deployment system is an intricate combination of medical devices and techniques designed to precisely deliver and deploy a stent within a blocked or narrowed vessel. The deployed stent enlarges the lumen of the target vessel, allowing for increased and improved blood flow through the previously blocked or narrowed vessel. Further, the stent provides structural support to the vessel, preventing it from collapsing or becoming re-narrowed.
[3] A conventional method for deploying a stent involves using an expandable balloon attached to a catheter. This balloon is inflated by injecting an inflation mixture, typically composed of saline and contrast dye. During the stent deployment, the balloon is inflated multiple times for optimal adjustments of the stent within the vessel. This makes the procedure time-consuming and may cause discomfort for the patient.
[4] Further, a stent deployment procedure using inflatable balloons encounters several other challenges. It is possible that the balloon may not inflate uniformly, for example, in case of dog-boning effect, where the stent expands more at distal ends than in the center. This may lead to suboptimal stent deployment, compromising its effectiveness and resulting in inadequate coverage of vascular lesions and insufficient support for the vessels. Misalignment or incomplete apposition of the stent to the artery wall can create gaps, leading to blood flow turbulence. Uneven expansion can damage vascular walls and increase the risk of restenosis (re-narrowing of the vessels) due to localized excessive pressure. Furthermore, there is a risk of tears or ruptures in the vascular walls, which can be life-threatening and require immediate medical intervention. Moreover, overinflation or encountering a particularly rigid section of plaque can cause the balloon to burst, leading to complications.
[5] Hence, there is a need for a stent deployment device that overcomes the problems associated with the conventional devices.
SUMMARY OF INVENTION
[6] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[7] The present disclosure relates to a device for to deploying a stent in the vessels. In an embodiment, the device includes a first disc, a second disc, a plurality of support bars and a flap assembly. The first disc and the second disc include a plurality of curved slots and a plurality of straight slots, respectively. The second disc is disposed distal to the first disc. Each support bar of the plurality of support bars extends through and is movable within a corresponding curved slot and a corresponding straight slot. The flap assembly is configured to toggle between a closed state and an expanded state. The flap assembly includes a plurality of first flaps and a plurality of second flaps arranged alternately. Each first flap of the plurality of first flaps is coupled to a corresponding support bar of the plurality of support bars. Each second flap of the plurality of second flaps is slidable over a corresponding one of the plurality of first flaps. In response to the rotation of the first disc in a first pre-defined direction, the plurality of support bars is configured to move radially outwards along the plurality of straight slots, causing the flap assembly to be in the expanded state. In the expanded state, a first end of each second flap of the flap assembly is disposed towards a first end of the corresponding first flap.
BRIEF DESCRIPTION OF DRAWINGS
[8] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[9] Fig. 1 depicts a device 10, according to an embodiment of the present disclosure.
[10] Figs. 2a depicts an exploded side view a handle 20 of the device 10, according to an embodiment of the present disclosure.
[11] Figs. 2b-2c depict side views of a knob 40 and a tube 46 of the handle 20, according to an embodiment of the present disclosure.
[12] Fig. 2d depicts a perspective view of a distal portion of a sheath 80, according to an embodiment of the present disclosure.
[13] Fig. 3 depicts an exploded view of a deployment assembly of the device 10, according to an embodiment of the present disclosure.
[14] Figs. 4a-4c depict various views of a first disc 114, according to an embodiment of the present disclosure.
[15] Fig. 5a depicts a coupling between the tube 46, the first disc 114, a second disc 118 and a plurality of support bars 120, according to an embodiment of the present disclosure.
[16] Figs. 5b-5c depict various views of the second disc 118, according to an embodiment of the present disclosure.
[17] Fig. 6a depicts a perspective front view of a flap assembly 130 of the device 10 in an expanded state, according to an embodiment of present disclosure.
[18] Fig. 6b depicts a perspective front view of the flap assembly 130 of the device 10 in a closed state, according to an embodiment of the present disclosure.
[19] Fig. 6c depicts a first flap 132 and a second flap 134 in the expanded state, according to an embodiment of the present disclosure.
[20] Fig. 6d depicts the first flap 132 and the second flap 134 in the closed state, according to an embodiment of the present disclosure.
[21] Fig. 6e depicts a perspective top view of a coupling between a deployment assembly and the flap assembly 130 of the device 10, according to an embodiment of the present disclosure.
[22] Fig. 6f depicts a perspective front view of the coupling between the deployment assembly and the flap assembly 130 of the device 10, according to an embodiment of the present disclosure.
[23] Fig. 6g depicts a perspective view of a ring 124 of the device 10, according to an embodiment of the present disclosure.
[24] Fig. 7 depicts a flowchart of a method 700 of operating the device 10, according to an embodiment of the present disclosure.
[25] Fig. 8a depicts a side view of the device 10 in the closed state before deployment of a stent 200, according to an embodiment of present invention.
[26] Fig. 8b depicts a side view of the device 10 in the expanded state during the deployment of the stent 200, according to an embodiment of present invention.
[27] Fig. 8c depicts a side view of the device 10 in the closed state after the deployment of the stent 200, according to an embodiment of present invention.
DETAILED DESCRIPTION OF THE DRAWINGS
[28] 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.
[29] 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.
[30] 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.
[31] Furthermore, the described includes, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific includes or advantages of a particular embodiment. In other instances, additional includes and advantages may be recognized in certain embodiments that may not be present in all embodiments. These includes and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[32] The present disclosure pertains to a device for deploying a stent at an intended zone within a vessel of a patient. The device includes a flap assembly that can be toggled between a closed state and an expanded state as needed during a stent deployment procedure. The stent is crimped on the flap assembly. The flap assembly is moved from the closed state to the expanded state to expand the stent and the flap assembly is moved back to the closed state to deploy the stent. Since the device of the present disclosure avoids the use of a balloon for stent deployment, the present disclosure obviates a need to inflate or deflate a balloon multiple times as seen in traditional balloon-based stent delivery systems. This reduces the time needed for the stent deployment process. The device operates without the need for saline or an inflation device, which simplifies the deployment process further. Further, the flap assembly provides uniform stent expansion, thereby, significantly reducing the risk of the dog-boning effect and chances of suboptimal stent deployment and associated issues. Additionally, the risk of tears and ruptures of the vascular walls associated with the conventional balloon-based stent deployment system is reduced, thereby improving patient outcomes during the procedure.
[33] In an embodiment, the flap assembly is controlled by an ergonomically designed handle, which is equipped with a knob that facilitates easy operation of the device. The user can simply rotate the knob in a desired direction to toggle the flap assembly from the closed state to the expanded state and back with the help of a knob. Thus, the overall usability is improved. The proposed design not only makes the device simple and easy to operate but also ensures consistent and reliable stent expansion, enhancing overall procedural efficiency and safety.
[34] Now referring to the figures, Fig. 1 illustrates an exemplary embodiment of a device 10 for deploying a stent at an intended zone within a vessel of a patient. The device 10 has a proximal end 10a and a distal end 10b. In an embodiment, the device 10 includes a handle 20, a sheath 80, a flap assembly 130 and a deployment assembly. The handle 20 is provided towards the proximal end 10a. A medical practitioner controls the deployment of the stent with the help of the handle 20. The handle 20 has a proximal end 20a and a distal end 20b. A hub 30 is coupled to the proximal end 20a of the handle 20. In an embodiment, the handle 20 includes a knob 40. The medical practitioners deploy the stent by manipulating the knob 40.
[35] The sheath 80 includes a proximal end 80a and a distal end 80b. The sheath 80 is coupled to the handle 20 using any adhesive technique, such as, without limitation, UV bonding, medical adhesives, etc. In an example implementation, the proximal end 80a of the sheath 80 is coupled to the distal end 20b of the handle 20 using UV boding. The distal end 80b of the sheath 80 is coupled to the deployment assembly. The deployment assembly is provided towards the distal end 10b of the device 10. The deployment assembly helps in deploying the stent at the target region within the vessels of the patient. The deployment assembly is coupled to the flap assembly 130. The flap assembly 130 is disposed on an outer surface of the sheath 80 towards the distal end 80b. The flap assembly 130 is configured to toggle between a closed state and an expanded state. In an embodiment, the stent is crimped onto an outer surface of the flap assembly 130. Deployment of the stent in the patient’s vessel is done by moving the flap assembly 130 from the closed state to the expanded state.
[36] The device 10 includes a support element 10c provided at the distal end 10b. The support element 10c is coupled to the sheath 80 using a coupling technique, such as, without limitation, UV bonding, fuse welding, medical adhesives, etc. In an embodiment, a proximal end of the support element 10c is coupled to distal end 80b of the sheath 80 using UV bonding. In an embodiment, the support element 10c has a tapered shape and has a smooth outer surface. The smooth surface and tapering shape of the support element 10c enable a smooth access into a lumen of the vessel without damaging the vascular walls as well as reduce trauma. The support element 10c may be made of a biocompatible material including, without limitation, polyether-block-amide (PEBAX), Nylon, Silicone, etc. In an exemplary implementation, the support element 10c is made of PEBAX. The support element 10c includes a lumen (not shown) extending for the length of the support element 10c. The lumen of the support element 10c provides a passage to the guidewire 36.
[37] Fig. 2a depicts an exploded view of the handle 20, according to an embodiment of the present disclosure. The handle 20 is ergonomically designed such that the medical practitioners can use the device 10 single handedly.
[38] In an embodiment, the handle 20 includes a first section 20c and a second section 20d, as shown in Fig. 2a. The first section 20c and the second section 20d are coupled with each other to form the handle 20. The handle 20 is configured to encase the hub 30 and the knob 40. The first section 20c and the second section 20d may be provided with a locking mechanism, such as, without limitation, press-fit, male-female coupling, etc., to lock with each other. In an exemplary implementation, the first section 20c and the second section 20d are locked using press-fit technique.
[39] A first aperture 22 is provided on a top surface of the handle 20. A portion of the knob 40 extends out of the first aperture 22. A second aperture 24 is provided towards the proximal end 20a. The second aperture 24 is configured to receive the hub 30. A base of the handle 20 may include an undulating surface 20e. The undulating surface 20e provides a better grip for the medical practitioner to hold the handle 20. The handle 20 may be made of a material, such as, without limitation, Acrylonitrile butadiene styrene (ABS), polyvinyl chloride (PVC), photopolymer, etc. In an exemplary implementation, the handle 20 is made of Acrylonitrile butadiene styrene (ABS).
[40] The knob 40 is generally circular, though the knob 40 may have any other suitable shape. In an embodiment, the knob 40 includes an undulating surface 40a, a proximal face 40b and a distal face 40c, as shown in Figs. 2b-2c. The undulating surface 40a provides a better grip for the user to hold the knob 40 and manipulate (e.g., rotate) the knob 40 in a desired direction. The knob 40 is rotatable both in clockwise direction and anti-clockwise direction. The user rotates the knob 40 in a first pre-defined direction to expand the flap assembly 130 (i.e., set the flap assembly 130 in the expanded state) and in a second pre-defined direction to close the flap assembly 130 (i.e., set the flap assembly 130 in the closed state). In an exemplary implementation, the knob 40 is rotated in the anti-clockwise direction to move the flap assembly 130 from the closed state to expanded state and the knob 40 is rotated in the clockwise direction to move the flap assembly 130 from the expanded state to the closed state. The knob 40 may be made of a material, such as, without limitation, Acrylonitrile butadiene styrene (ABS), PVC, photopolymer, etc. In an exemplary embodiment, the knob 40 is made of Acrylonitrile butadiene styrene (ABS).
[41] In an embodiment, the hub 30 has a hollow, conical structure where the diameter of the hub 30 reduces from a proximal end of the hub 30 towards a distal end of the hub 30. The hub 30 may have any other shape without deviating scope of the present disclosure. The hub 30 is configured to provide passage for a guidewire 36, as shown in Fig. 2a. The guidewire 36 extends from the proximal end 10a to the support element 10c of the device 10. The hub 30 may be made of a material, such as, without limitation, polycarbonate, PEBAX, nylon, etc. In an embodiment, the hub 30 is made of polycarbonate.
[42] The distal face 40c of the knob 40 is coupled to a tube 46 using a coupling techniques, such as, UV bonding, press-fit coupling, medical adhesives, etc. In an exemplary implementation, the tube 46 is coupled to the distal face 40c of the knob 40 using UV bonding technique. The tube 46 is configured to rotate in the same direction as the knob 40.
[43] The tube 46 generally has a hollow, tubular structure extending from a proximal end 46a to a distal end 46b. The proximal end 46a of the tube 46 is coupled to the distal face 40c of the knob 40, as shown in Fig. 2c. In an embodiment, the tube 46 has a reducing stepped configuration towards the distal end 46b. In an embodiment, a distal tip 46c of the tube 46 has a triangular prism-like shape, though the distal tip 46c may have any suitable shape. The triangular prism-like shape provides a better grip and a proper amount of torque to rotate the first disc 114. The tube 46 is configured to rotate in response to the rotation of the knob 40. The tube 46 includes a lumen (not shown) extending from the proximal end 46a to the distal end 46b. The lumen of the tube 46 is configured to provide a passage for the guidewire 36. A hole 40d is provided at a center of the knob 40 through which the guidewire 36 passes, as shown in Fig. 2b. A length and a diameter of the tube 46 may range between 800 mm to 1000 mm and 1 mm to 4 mm, respectively. In an exemplary embodiment, the length and the diameter of the tube 46 is 900mm and 1.5 mm, respectively. The tube 46 may be made of a biocompatible material, such as, without limitation, PEBAX, Nylon, Polyether ether ketone (PEEK), polyurethane, etc. In an exemplary implementation, the tube 46 is made of PEEK.
[44] The sheath 80 is inserted into the patient’s vessels. The sheath 80 generally has a hollow, tubular structure extending from a proximal end 80a to a distal end 80b, thereby defining a lumen. The lumen of the sheath 80 is configured to receive at least a partial length of the tube 46. The distal end 80b of the sheath 80 includes a plurality of slits 86. In an exemplary implementation, the plurality of slits 86 includes three slits, as shown in Fig. 2d. A length and a diameter of the sheath 80 may range between 750 mm to 1000 mm and 3 mm to 8 mm, respectively. In an exemplary implementation, the length and the diameter of the sheath 80 are 850 mm and 5 mm, respectively. The sheath 80 may be made of a biocompatible material, such as, without limitation, PEBAX, Nylon, polyurethane, etc. In an exemplary implementation, the sheath 80 is made of PEBAX.
[45] An exemplary deployment assembly is illustrated in Fig. 3. In an embodiment, the deployment assembly of the device 10 includes a first disc 114, a second disc 118, a plurality of support bars 120 (hereinafter, support bars 120) and a ring 124 as shown in Fig. 3.
[46] The first disc 114 is disposed within the sheath 80 towards the distal end 80b of the sheath 80. The first disc 114 is operatively coupled to knob 40. In an embodiment, the first disc 114 is coupled to the tube 46, which is coupled to the knob 40, as shown in Fig. 4a. For example, the first disc 114 is coupled to the distal tip 46c of the tube 46. A hole 114a is provided at a center of the first disc 114. The hole 114a is configured to receive the distal tip 46c of the tube 46. The cross-sectional size and shape of the hole 114a correspond to the cross-sectional size and shape of the distal tip 46c of the tube 46. In an exemplary the hole 114a is triangular in shape. The first disc 114 may be coupled to the tube 46 using a coupling techniques, such as, without limitation, UV bonding, press-fit locking, medical adhesives, etc. In an exemplary implementation, the first disc 114 is coupled to the tube 46 using UV bonding. The first disc 114 is configured to rotate in response to the rotation of the tube 46. The first disc 114 rotates in the same direction as that of the rotation of the tube 46. In other words, in response to the rotation of the knob 40 in the first pre-defined direction or in a second pre-defined direction, the first disc 114 is configured to rotate in the same direction as the rotational direction of the knob 40 (i.e., in the first pre-defined direction and the second pre-defined direction, respectively).
[47] The first disc 114 includes a plurality of slots 114b. In an exemplary embodiment, the plurality of slots 114b of the first disc 114 are curved (hereinafter, curved slots 114b), as shown in Fig. 4b. Each of the curved slots 114b is configured to receive one of the support bars 120. The curved slots 114b provide a path for the support bars 120 to follow and move between a point A1 and a point A2 in response to rotational motion of the first disc 114, as shown in Figs. 4b-4c. In an embodiment, in response to the rotation of the first disc 114 in a first pre-defined direction (e.g., anticlockwise direction), the plurality of support bars 120 moves from the point A1 to the point A2 within the respective curved slots 114b, as shown in Fig. 4b. Similarly, in response to the rotation of the first disc 114 in the second pre-defined direction (e.g., clockwise direction), the plurality of support bars 120 moves from the point A2 to the point A1 within the respective curved slots 114b, as shown in Fig. 4c. The first disc 114 may be made of a biocompatible material, such as, without limitation, stainless steel, nitinol, titanium, etc. In an exemplary embodiment, the first disc 114 is made of stainless steel.
[48] The second disc 118 is disposed within the sheath 80 distal to the first disc 114 as shown in Figs. 3 and 5a. In an embodiment, the second disc 118 remains stationary. The second disc 118 is coupled to the first disc 114 with the help of the plurality of support bars 120. The second disc 118 prevents the rotation of the plurality of support bars 120 and guides the plurality of support bars 120 to move radially inward and outward depending upon the rotational direction of the first disc 114. The second disc 118 includes a plurality of slots 118b. In an exemplary embodiment, the plurality of slots 118b are straight (hereinafter, straight slots 118b), as shown in Fig. 5b. Each of the straight slots 118b is configured to receive one of the plurality of support bars 120. The second disc 118 is placed such that each of the curved slots 114b of the first disc 114 aligns with a corresponding straight slot 118b of the straight slots 118b of the second disc 118. The straight slots 118b provide a path for the plurality of support bars 120 to move radially between a point B1 and a point B2. The second disc 118 is supported by the plurality of support bars 120. The second disc 118 may be made of a biocompatible material, such as, without limitation, stainless steel, nitinol, titanium, etc. In an exemplary embodiment, the second disc 118 is made of stainless steel.
[49] When the first disc 114 rotates, the plurality of support bars 120 attempt to rotate along with the first disc 114. As the second disc 118 is stationary, the movement of the plurality of support bars 120 is restricted only in a radial direction along the straight slots 118b, which causes the support bars 120 to traverse path of the respective curved slot 114b. In other words, in response to the rotation of the first disc 114, the plurality of support bars 120 are configured to move radially between points B1 and B2 along respective straight slots 118b and move along the respective curved slots 114b between points A1 and A2 depending upon the rotational direction of the first disc 114. For example, when the first disc 114 rotates in the first pre-defined direction (e.g., anticlockwise direction), each support bar 120 of the plurality of support bars 120 moves in the radially outward direction from the point B1 to the point B2 along the respective straight slot 118b (as shown in Fig. 5b) and from the point A1 to the point A2 along the respective curved slot 114b (as shown in Fig. 4b). Upon reaching the point B2, further movement of the plurality of support bars 120 is prevented. As a result, further rotation of the first disc 114 in the anticlockwise direction is prevented.
[50] Similarly, when the first disc 114 rotates in the second pre-defined direction (e.g., clockwise direction), the plurality of support bars 120 moves in the radially inward direction from the point B2 to the point B1 along the respective straight slots 118b (as shown in Fig. 5c) and from the point A2 to the point A1 along the respective curved slot 114b (as shown in Fig. 4c). Upon reaching the point B1, further movement of the plurality of support bars 120 is prevented, thereby preventing further rotation of the first disc 114 in the clockwise direction.
[51] Each support bar 120 of the plurality of support bars 120 extends through a respective curved slot 114b and a respective straight slot 118b. In an embodiment, a proximal end of each support bar 120 is disposed proximal to the first disc 114 and a distal end of each support bar 120 is disposed distal to the second disc 118 (as shown in Fig. 5a). The plurality of support bars 120 may have a length and a diameter ranging between 1.5 mm to 5 mm and 0.5 mm to 3 mm, respectively. In an exemplary implementation, the length and the diameter of the plurality of support bars 120 are 2.5 mm and 1 mm, respectively. The plurality of support bars 120 may be made of a biocompatible material, such as, without limitation, stainless steel, nitinol, titanium, etc. In an exemplary implementation, the plurality of support bars 120 is made of stainless steel.
[52] In an embodiment, the flap assembly 130 includes a plurality of first flaps 132 (hereinafter, first flaps 132) and a plurality of second flaps 134 (hereinafter, second flaps 134) arranged alternately, as shown in Fig. 6a. The first flaps 132 and the second flaps 134 generally have a curved body having an outer surface and an inner surface. The first flaps 132 and the second flaps 134 may have same or different width. In an exemplary implementation, the width of the first flaps 132 is larger than the width of the second flap 134. The flap assembly 130 includes three or more first flaps 132 and three or more second flaps 134. In the depicted embodiment, the flap assembly 130 includes three first flaps 132 and three second flaps 132. Each of the second flaps 134 is slidably coupled with a corresponding one of the first flaps 132. Further, each second flap 134 may also be rotatably coupled to another first flap 132 of the plurality of first flaps 132 using a hinge mechanism (depicted in Figs. 6a – 6b), though any other suitable technique, for example, pulley mechanism may be used. The first flaps 132 and the second flaps 134 may be made of a biocompatible material, such as, without limitation, stainless steel, nitinol, titanium, etc. In an exemplary implementation, the first flaps 132 and the second flaps 134 are made of nitinol.
[53] For reasons of clarity, slidable coupling of the first flaps 132 and the second flaps 134 is explained below with the help of one first flap 132 and one second flap 134. Figs. 6c and 6d depict the first flap 132 and the second flap 134 in the expanded state and the closed state, respectively, according to an embodiment of the present disclosure. The first flap 132 has a first end 132c and a second end 132b, and the second flap 134 has a first end 134b and a second end 134c (as depicted in Figs. 6c – 6d). In an embodiment, the second flap 134 is configured to slide over the first flap 132. In an embodiment, the first flap 132 includes a ridge 132a provided towards each of a proximal and a distal end of the first flap 132. The ridge 132a extends along a peripheral side of the first flap 132. In an embodiment, the second flap 134 includes a notch 134a provided towards each of a proximal and a distal end of the second flap 134. The notch 134a extends along a peripheral side of the second flap 134. Each ridge 132a of the first flap 132 is seated within the respective notch 134a of the second flap 134 and allows the second flap 134 to slide over the first flap 132, thereby establishing the slidable coupling between the first flap 132 and the corresponding second flap 134. It should be understood that any other functionally equivalent sliding mechanism may be used without deviating from the scope of the present disclosure.
[54] In an embodiment, the second flap 134 is slidable over the first flap 132 between a first position and a second position. In the closed state, the second flap 134 is at the first position. In the first position, the second flap 134 overlaps at least partially with the corresponding first flap 132 such that the inner surface of the second flap 134 faces the outer surface of the first flap 132 and the first end 134b of the second flap 134 is disposed towards the second end 132b of the first flap 132, as shown in Fig. 6d. In the expanded state, the second flap 134 is at the second position. In the second position, the first end 134b of the second flap 134 is disposed towards the first end 132c of the corresponding first flap 132, as shown in Fig. 6c. In an embodiment, in the second position, the first end 134b of the second flap 134 substantially aligns with the first end 132c of the first flap 132.
[55] Each first flap 132 is operatively coupled to a corresponding support bar 120 of the plurality of the support bars 120. In an embodiment, each first flap 132 includes a rod 136 protruding from the inner surface of the first flap 132. The rod 136 is coupled to a respective support bar 120 of the plurality of support bars 120. In an embodiment, each rod 136 includes a hole 128, as shown in Fig. 6a. The hole 128 is configured to receive a distal portion of the corresponding support bar 120, thereby establishing the coupling between the first flap 132 and the corresponding support bar 120 as shown in Fig. 6e. The rod 136 may be coupled with the corresponding support bar 120 using a coupling technique, such as, without limitation, laser welding, soldering, brazing, etc. In an exemplary implementation, the rod 136 is coupled to the corresponding support bar 120 using laser welding.
[56] In an embodiment, the rod 136 and the first flap 132 form an integrated structure. In another embodiment, the rod 136 and the first flap 132 may be separate structures and are coupled to each other using a coupling technique, such as, without limitation, laser welding, soldering, brazing, etc. The rod 136 passes through a corresponding slit 86 of the plurality of slits 86 provided on the sheath 80 and a corresponding cavity 126 (depicted in Fig. 6f) provided on the ring 124. The ring 124 is disposed within the sheath 80 distal to the second disc 118. The ring 124 provides support to the first flaps 132. An exemplary ring 124 is depicted in Fig. 6g. The ring 124 may have a diameter and length ranging between 3 mm to 8 mm and 1 mm to 3 mm, respectively. In an exemplary implementation, the diameter and length of the ring 124 are 5 mm and 1.5 mm, respectively. The ring 124 may be made of a biocompatible material, such as, without limitation, stainless steel, nitinol, titanium, etc. In an exemplary implementation, the ring 124 is made of stainless steel.
[57] The first flap 132 is configured to move radially in response to radial movement of the support bar 120. In an embodiment, in response to the plurality of support bars 120 moving radially outward along the plurality of straight slots 118b of the second disc 118 (due to the rotation of the first disc 114 in the first pre-defined direction), the rods 136 move radially outward, thereby pushing the first flaps 132 to move in the outward direction. The outward movement of the first flaps 132 causes the second flaps 134 to slide out of the corresponding first flaps 132. Once the second flaps 134 are in the second position, the flap assembly 130 is unfolded and is in the expanded state, as shown in Fig. 6a.
[58] Similarly, in response to the plurality of support bars 120 moving radially inward along the plurality of straight slots 118b of the second disc 118 (due to the rotation of the first disc 114 in the second pre-defined direction), the rods 136 move radially inward, thereby pulling the first flaps 132 to move in the inward direction. This inward movement of the first flaps 132 causes the second flaps 134 to slide into the corresponding first flaps 132. Once the second flaps 134 are in the first position, the flap assembly 130 is folded and is in the closed state, as shown in the Fig. 6b. The overall diameter of the flap assembly 130 in the expanded state is more than the overall diameter of the flap assembly 130 in the closed state.
[59] Fig. 7 depicts a flowchart of a method 700 of operating the device 10 according to an embodiment of the present disclosure.
[60] At step 702, a stent 200 is crimped on the flap assembly 130 using any suitable technique. At this stage, the flap assembly 130 is at the closed state.
[61] At step 704, the sheath 80 is advanced to a target location within a vessel 60 of the patient with the help of the guidewire 36. The flap assembly 130 remains in the closed state as depicted in Fig. 8a.
[62] At step 706, the flap assembly 130 is expanded. In an embodiment, the user rotates the knob 40 in the anticlockwise direction to move the flap assembly 130 from the closed state to the expanded state. Upon expansion of the flap assembly 130, the stent 200 is expanded from its crimped state, as shown in Fig. 8b.
[63] Upon expansion of the stent 200, the flap assembly 130 is moved to the closed state at step 708. In an embodiment, the user rotates the knob 40 in the clockwise direction to move the flap assembly 130 from the expanded state to the closed state. Upon closing the flap assembly 130, the stent 200 is fully deployed at the target location, as shown in Fig. 8c.
[64] At step 710, the sheath 80 is retracted from the vasculature system of the patient.
[65] 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 (10) for deploying a stent, the device (10) comprising:
a. a first disc (114) comprising a plurality of curved slots (114b);
b. a second disc (118) distal to the first disc (114), the second disc (118) comprising a plurality of straight slots (118b);
c. a plurality of support bars (120), each support bar (120) of the plurality of support bars (120) extending through and movable within a corresponding curved slot (114b) and a corresponding straight slot (118b); and
d. a flap assembly (130) configured to be toggled between a closed state and an expanded state, the flap assembly (130) comprising:
i. a plurality of first flaps (132) and a plurality of second flaps (134) arranged alternately;
ii. each first flap (132) of the plurality of first flaps (132) is coupled to a corresponding support bar (120) of the plurality of support bars (120) and is configured to move radially in response to radial movement of the support bar (120);
iii. each second flap (134) of the plurality of second flaps (134) is slidable over a corresponding one of the plurality of first flaps (132);
e. wherein in response to the rotation of the first disc (114) in a first pre-defined direction, the plurality of support bars (120) is configured to move radially outwards along the plurality of straight slots (118b), causing the flap assembly (130) to be in the expanded state;
f. wherein in the expanded state, a first end (134b) of each second flap (134) of the flap assembly (130) is disposed towards a first end (132c) of the corresponding first flap (132).
2. The device (10) as claimed in claim 1, wherein in the second position, the first end (134b) of the second flap (134) substantially aligns with the first end (132c) of the first flap (132).
3. The device (10) as claimed in claim 1, wherein the plurality of support bars (120) is configured to move radially inwards along the plurality of straight slots (118b) in response to the rotation the first disc (114) in a second pre-defined direction, causing the flap assembly (130) to be in the closed state, wherein in the closed state, each second flap (134) of the flap assembly (130) at least partially overlaps the corresponding first flap (132) of the flap assembly (130) and the first end (134b) of the second flap (134) is disposed towards a second end (132b) of the corresponding first flap (132).
4. The device (10) as claimed in claim 1, wherein the device (10) comprises a knob (40) operatively coupled to the first disc (114), wherein in response to the rotation of the knob (40) in the first pre-defined direction or in a second pre-defined direction, the first disc (114) is configured to rotate in the first pre-defined direction and the second pre-defined direction, respectively.
5. The device (10) as claimed in claim 2, wherein the device (10) comprises a tube (46) coupled to the knob (40) at a proximal end (46a) of the tube (46) and coupled to the first disc (114) at a distal end (46b) of the tube (46), the tube (46) is configured to rotate in response to the rotation of the knob (40).
6. The device (10) as claimed in claim 1, wherein each first flap (132) includes a ridge (132a) slidable within a corresponding notch (134a) provided on the corresponding second flap (134).
7. The device (10) as claimed in claim 1, wherein the device (10) includes a hub (30) coupled to a proximal end (20a) of a handle (20) and configured to provide a passage for a guidewire (36).
8. The device (10) as claimed in claim 1, wherein the first disc (114), the second disc (118) and the plurality of support bars (120) are disposed within a sheath (80) and the flap assembly (130) is disposed on an outer surface of the sheath (80).
9. The device (10) as claimed in claim 1, wherein each first flap (132) includes a rod (136) protruding from an inner surface of the first flap (132), the rod (136) comprising a hole (128) configured to receive a distal portion of the corresponding support bar (120) of the plurality of support bars (120).