Delivery system for a self-expandable braided stent

Abstract

A delivery system for delivering a self-expandable braided stent is disclosed. The delivery system includes a handle containing a roller assembly. The roller assembly includes a roller, a base plate, a connecting shaft, and a slider block. The slider block is supported on the inner tube. The delivery system includes a hypotube fixedly coupled to the slider block and coaxially receiving the inner tube. The stent is mounted on the hypotube in a crimped state. An outer sheath is disposed over the hypotube to cover the stent. When the roller rotates, the slider block allows forward and rearward movement of the hypotube along a longitudinal axis 'x' over the inner tube relative to the outer sheath.

Description

[Technical Field]

[0001] The present invention relates to a delivery system, and more particularly, to a delivery system for the delivery of a self-expandable braided stent at a target location. [Background technology]

[0002] Self-expanding stents are widely used in body vessels, ducts, or other cavities to restore normal blood flow. Introduction and deployment of self-expanding stents is facilitated using a corresponding stent delivery system. The self-expanding stent is loaded onto the delivery system in a contracted state maintained by a sheath. Once the delivery system with the stent reaches the target location, the sheath is withdrawn, exposing the stent and thereby radially expanding it. The expanded stent exerts a radial force at the target location, re-establishing patency of the body lumen or duct. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] U.S. Patent No. 9,023,095(B2) Summary of the Invention [Problem to be solved by the invention]

[0004] Self-expanding stents are generally fabricated by braiding or laser cutting. Conventional delivery systems for deploying self-expandable braided stents mostly operate with a switch and lock-mediated push-pull mechanism. For example, prior art U.S. Pat. No. 9,023,095 (B2) discloses a delivery system for self-expandable stents based on a slide mechanism having components such as a handle, a driver assembly, a pusher lock, a deployment lock, and a switch. The switch is connected to a lumen that slides over a support tube. In this delivery system, the operator must push the stent multiple times to deliver it to a specific location, so the operator must be very careful during stent deployment / delivery. The operator must also note that the deployment lock must be unlocked for the final push to fully deliver / deploy the stent to the targeted location. Therefore, the delivery systems disclosed in the above patent documents are very complicated and inconvenient for operators to use, thereby increasing the possibility of inaccurate stent deployment and making the delivery system and its mechanism prone to errors. Also, this delivery system is time intensive, requiring long procedure times for stent deployment.

[0005] Furthermore, targeting long lesions presents significant challenges due to the increased procedure time associated with conventional delivery systems. Interventional techniques for treating long lesions include the use of multiple overlapping stents or a single long stent. However, given that conventional delivery systems are already associated with increased procedure times, the procedure time for deploying a long stent is increased several-fold, thereby simultaneously increasing the risks of stent migration, vessel injury, unnecessary stent invagination, etc.

[0006] Therefore, to overcome the shortcomings of conventional delivery systems, there is a need to devise a delivery system for braided self-expandable stents that is operator-friendly, easy to operate, and delivers stents (including long stents) in a controlled manner and with reduced procedure time. [Means for solving the problem]

[0007] The present invention relates to a delivery system for delivering a self-expanding braided stent. The delivery system includes a handle disposed toward a proximal end of the delivery system. The handle surrounds a roller assembly having rollers capable of rotating clockwise and counterclockwise. The roller assembly additionally includes a base plate, a connecting shaft, and a slider block. The slider block is supported by an inner tube.

[0008] The delivery system also includes a hypotube having a proximal end and a distal end. The proximal end is coupled to the slider block of the roller assembly. The hypotube is provided with a stent driver disposed toward the distal end. The stent driver is positioned a predetermined distance from the distal end of the delivery system. The distal end of the hypotube is provided with a soft tip. The hypotube is configured to mount a self-expandable braided stent adjacent the soft tip.

[0009] An outer sheath is coupled to the distal end of the handle and disposed over the hypotube, the outer sheath being configured to cover the self-expanding braided stent in a crimped state.

[0010] When the rollers rotate, the slider block is configured to translate the rotational motion of the roller assembly into forward and rearward movement of the hypotube along the longitudinal axis of the delivery system relative to the outer sheath over the inner tube.

[0011] The stent driver is configured to engage the self-expanding braided stent and push the self-expanding braided stent out of the outer sheath to cause full radial expansion of the self-expanding braided stent.

[0012] The foregoing and other features and advantages of the present invention will become more apparent from the following detailed description taken in conjunction with the accompanying drawings.

[0013] The above summary and the following detailed description of exemplary embodiments will be better understood when read in conjunction with the assigned drawings. For the purpose of illustrating the disclosure, exemplary structures of the disclosure are shown in the drawings. However, the disclosure is not limited to the particular methods and techniques disclosed herein. Furthermore, those skilled in the art will understand that the drawings are not to scale. [Brief explanation of the drawings]

[0014] [Figure 1] 1 is an isometric view of a delivery system 100 according to an embodiment of the present invention. [Figure 1A] 1 is a cross-sectional view of a delivery system 100 showing internal components according to an embodiment of the present invention. [Figure 2] 1 shows a roller assembly 107 coupled with a hypotube 105 according to an embodiment of the present invention. [Figure 2A] 1 shows a roller 107a and a base plate 107b according to an embodiment of the present invention. [Figure 2B] 1 shows a connecting shaft 107c according to an embodiment of the present invention. [Figure 2C] 1 shows a slider block 107d according to an embodiment of the present invention. [Figure 2D] FIG. 1 is a side view of a roller assembly 107 according to an embodiment of the present invention. [Figure 3] A locking screw 109 is shown according to an embodiment of the present invention. [Figure 4] 1 shows a stent driver 105d according to an embodiment of the present invention. [Figure 5]1 shows a stent mounted on a delivery system 100 in a collapsed state according to an embodiment of the present invention. [Figure 5A] FIG. 10 is a close-up view of the engagement of prong portion 5d2 with a stent according to an embodiment of the present invention. [Figure 6] 1 shows a locking pin 30 coupled to a roller 107a according to an embodiment of the present invention. [Figure 7] 1 illustrates a method for operation of delivery system 100 for deployment of a stent according to an embodiment of the present invention. [Figure 8A] 1 illustrates the movement of roller 107a and its effect on hypotube 105 for deployment of a stent according to an embodiment of the present invention. [Figure 8B] 1 illustrates the movement of roller 107a and its effect on hypotube 105 for deployment of a stent according to an embodiment of the present invention. [Figure 8C] 1 illustrates the movement of roller 107a and its effect on hypotube 105 for deployment of a stent according to an embodiment of the present invention. [Figure 8D] 1 illustrates the movement of roller 107a and its effect on hypotube 105 for deployment of a stent according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0015] Before describing the present invention in detail, definitions of certain words or phrases used throughout this patent document are set forth. The terms "include" and "comprise" and their derivatives mean an open-ended inclusion, and the term "or" is inclusive and / or. The phrases "coupled with" and "associated therewith," and their derivatives, may mean 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, etc. Definitions of certain words and phrases are provided throughout this patent document, and one of ordinary skill in the art will understand that such definitions apply in many or most instances to past and future uses of such defined words or phrases.

[0016] References throughout this application to "one embodiment," "an embodiment," or similar language mean 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 application may, but do not necessarily, all refer to the same embodiment, but may 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 list 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.

[0017] Although the operations of exemplary embodiments of the disclosed methods may be described in a particular order for convenience of presentation, it should be understood that the disclosed embodiments may include an order of operations that differs from the particular order disclosed. For example, operations described sequentially may in some cases be rearranged or performed simultaneously. Moreover, descriptions and disclosures provided in connection with one particular embodiment are not limited to that embodiment but may apply to any disclosed embodiment herein. Moreover, for the sake of brevity, the accompanying figures may not show the various ways in which the disclosed systems, methods, and apparatuses can be used in combination with other systems, methods, and apparatuses.

[0018] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. Those skilled in the art will recognize that embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other cases, additional features and advantages may be recognized in particular 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 assigned claims, or may be learned by practice of the embodiments described hereinafter.

[0019] In accordance with the present disclosure, a delivery system for deployment of a self-expanding braided stent (hereinafter referred to as a "stent") is disclosed. The delivery system of the present invention is used to deliver the stent to a target site / location. The target site of the present invention may include a diseased peripheral vasculature, biliary vasculature, or coronary vasculature lesion.

[0020] The delivery system of the present invention includes various components, such as a handle, a hypotube, a roller assembly coupled to the hypotube, a stent driver attached to the hypotube, a soft tip, an outer sheath, and an inner tube. The roller assembly includes a roller, a base plate, a connecting shaft, a slider block, and other components. The roller assembly of the present invention is very easy to use and can be operated with one hand, significantly reducing the operator's effort required for stent deployment. The only action required by the operator is to rotate the roller; the remaining components move as a result of the roller rotation to deploy the stent at the target site. Furthermore, the use of the roller assembly of the present invention reduces overall procedure time. Furthermore, by using the roller assembly of the present invention, delivery of long stents can be performed with minimal effort and minimal procedure time, as opposed to conventional delivery systems.

[0021] The self-expanding braided stent to be delivered is first preloaded onto the distal end of the hypotube and maintained in a crimped state within the outer sheath. Rotation of the roller by the operator's thumb facilitates deployment of the stent at the target site. Specifically, rotation of the roller initiates movement of other components of the roller assembly that cause movement of the hypotube along the longitudinal axis of the delivery system for stent deployment.

[0022] The operator can rotate the roller in either a clockwise or counterclockwise direction. The roller is capable of 360-degree rotation, with first and second half cycles of 180 degrees each. One complete rotation of the roller facilitates forward and rearward movement of the hypotube along the longitudinal axis of the delivery system relative to the outer sheath, regardless of the direction of rotation. The first half cycle of rotation of the roller moves the hypotube forward a first predetermined distance, while the second half cycle of rotation moves the hypotube rearward, advancing the first predetermined distance. Thus, one complete rotation of the roller results in zero displacement of the hypotube relative to its original position. Note that the hypotube is the only component of the delivery system of the present invention that reciprocates along the longitudinal axis when the roller is fully rotated.

[0023] As the hypotube moves forward, it is expelled from the outer sheath, at least partially exposing the stent. Continued forward movement of the hypotube allows the stent driver to fully push the stent out of the outer sheath, thereby causing the entire stent to expand for deployment at the target site. The number of roller rotations required to deploy the stent depends on the length of the stent being deployed; i.e., the number of rotations can be directly proportional to the length of the stent.

[0024] Thus, due to the presence of the roller assembly of the present invention, the delivery system of the present invention is easy to handle and operate, and also allows for the delivery of stents in a controlled manner with reduced procedure times.

[0025] Referring to the drawings, Figure 1 shows a delivery system 100 of the present invention. Delivery system 100 is used for deployment of at least one self-expandable braided stent (or stents) at a target site, including, but not limited to, a lesion in the diseased peripheral vasculature, biliary vasculature, or coronary vasculature.

[0026] The delivery system 100 of the present invention can be used to deploy stents of various lengths. In one embodiment, the delivery system 100 is capable of deploying stents having lengths ranging from 20 mm to 250 mm. Thus, in addition to small and medium-sized stents, the delivery system 100 of the present invention can easily deliver stents having longer lengths to a target site.

[0027] 1 and 1A, the stent is part of the delivery system 100. The assembly of the delivery system 100 and the stent mounted thereon (in a crimped state) is packaged as is. If needed, the packaged assembly is intended to be used by the operator for further delivery and deployment of the stent (using the methods described below) without any modifications or amendments to the stent or the delivery system 100.

[0028] As shown in Figure 1, delivery system 100 extends along a longitudinal axis x' from a proximal end 100a to a distal end 100b. Delivery system 100 includes multiple components aligned along the longitudinal axis x' of delivery system 100. As shown in the illustrative illustration of Figure 1, the multiple components of delivery system 100 include a handle 101, an outer sheath 103, and a soft tip 105a.

[0029] As can be seen in Figure 1, handle 101 is located toward the proximal end 100a of delivery system 100. Handle 101 is structured to provide an operator with a proper grip for easy and controlled deployment of the stent. Handle 101 includes a predetermined shape and dimensions that provide ergonomic benefits. Thus, the shape and dimensions of handle 101, i.e., length, diameter / width, are selected to maximize ease and comfort for the operator.

[0030] The handle 101 is constructed from a predetermined material, which may include, without limitation, ABS (acrylonitrile butadiene styrene) plastic, polycarbonate, HDPE (high density polyethylene), polypropylene, polyethylene, etc. In one embodiment, the handle 101 is constructed from ABS.

[0031] The handle 101 forms a housing that acts as an enclosure for housing various other components that function in a synchronized manner to manipulate and control the deployment of the stent through the delivery system 100. In one embodiment, the handle 101 is in the form of a hollow, shell-like structure that includes cavities for housing other components discussed below (shown in FIG. 1A).

[0032] As seen in FIGS. 1 and 1A, handle 101 includes proximal end 101a, distal end 101c, and central section 101b defined therebetween. In one exemplary embodiment, Luer hub 10 is disposed at proximal end 101a of handle 101. Luer hub 10 can also be configured to be partially disposed within handle 101. As shown in the exemplary embodiment of FIG. 1A, at least 10-20% of Luer hub 10 is disposed outside handle 101, thereby defining proximal end 100a of delivery system 100. Luer hub 10 facilitates insertion of a guidewire and, if desired, injection of contrast media, as is conventionally known.

[0033] 1A, the luer hub 10 can be coupled to the inner tube 20. The coupling between the inner tube 20 and the luer hub 10 can be achieved via a predetermined attachment means. In one exemplary embodiment, the luer hub 10 is coupled onto the inner tube 20 via an ultraviolet (UV) adhesive process.

[0034] 1A, inner tube 20 includes proximal end 20a and distal end 20b. Proximal end 20a of inner tube 20 is coupled to Luer hub 10, while distal end 20b terminates near distal end 101c along longitudinal axis x' of delivery system 100.

[0035] The inner tube 20 may be constructed of a predetermined material such as stainless steel, nitinol, or other metal alloys. In one exemplary embodiment, the inner tube 20 is constructed of stainless steel.

[0036] The distal end 101c of the handle 101 includes a hole to allow passage of the hypotube 105. Additionally, as shown in FIG. 1A, the distal end 101c of the handle 101 includes a flushing port 101d. The flushing port 101d is fixedly attached to the outer sheath 103. In one embodiment, the flushing port 101d along with the outer sheath 103 are attached to the distal end 101c of the handle 101 via an overmolding technique (injection molding). The flushing port 101d is provided for flushing the outer sheath 103 and for introducing contrast media between the catheter and the hypotube 105.

[0037] The outer sheath 103 extends over the hypotube 105, such that the outer sheath 103 is coaxially disposed over the hypotube 105. As shown in FIG. 5, the outer sheath 103 is in a crimped state and covers the stent 200 mounted on the hypotube 105 toward the distal end 100b of the delivery system 100. Thus, the stent 200 is maintained in a crimped state within the outer sheath 103 prior to deployment. In one embodiment, as shown in FIGS. 1 and 5, the outer sheath 103 covers the hypotube 105 in a manner such that the stent 200 is completely covered while the soft tip 105a remains exposed by the outer sheath 103.

[0038] The outer sheath 103 may be a single-layer or multi-layer structure. In some embodiments, the outer sheath 103 is a three-layer structure having a first layer, a second layer, and a third layer. The first layer is the innermost layer, which may be composed of polytetrafluoroethylene (PTFE), high-density polyethylene (HDPE), or the like. In some embodiments, the first layer is composed of PTFE. The second layer may be in the form of a braided layer formed by braiding flat or round wires, such as Nitinol or stainless steel. In some embodiments, the second layer is formed by braiding round stainless steel wires in a one-over-one pattern. The third layer is the outermost layer, which may be composed of polyether block amide, PTFE, or the like. In some embodiments, the third layer is composed of a variant of a polyether block amide block copolymer called PEBAX. It should be noted that the above details of the outer sheath 103 are merely exemplary in nature, and outer sheaths 103 having different structural details may be used in accordance with the teachings of the present invention.

[0039] The central section 101b of the handle 101 may include a roller assembly 107. The roller assembly 107 is disposed within the housing of the handle 101 and is rotatably coupled to the handle 101. The roller assembly 107 includes multiple components. In one exemplary embodiment, shown in FIGS. 2-2D, the roller assembly 107 includes rollers 107a, a base plate 107b, a connecting shaft 107c, and a slider block 107d. As shown in FIG. 2, the slider block 107d may receive the hypotube 105. All components of the roller assembly 107 are assembled together to facilitate movement of the hypotube 105 along the longitudinal axis 'x' of the delivery system 100, thereby providing easy and smooth deployment of a stent (described in detail below) at the target site.

[0040] When rotated by an operator, roller 107a is capable of rotating in a clockwise and counterclockwise direction. Roller 107a is partially housed within handle 101 in a manner such that a portion of roller 107a protrudes from the periphery of handle 101 through opening 101b1, as shown in Figures 1, 1A, and 6. Such an arrangement allows an operator easy access to roller 107a for rotating roller 107a.

[0041] The roller 107a is constructed of a predetermined material, which may include, without limitation, ABS, polycarbonate, nylon, carbon, fiber, etc. In one exemplary embodiment, the roller 107a is constructed of ABS.

[0042] The roller 107a has a predetermined shape. The shape of the roller 107a may include, without limitation, a circle, a sphere, an oval, a polygon, a scalloped circle, etc. In one exemplary embodiment, the roller 107a is circular in shape. The roller 107a includes predetermined dimensions. In one embodiment, the roller 107a includes a thickness in the range of 4 mm to 15 mm and a diameter in the range of 25 mm to 55 mm.

[0043] With the above shape and dimensions, the roller 107a includes two oppositely disposed sides (a first side a1 shown in FIG. 2A and a second side (not shown)) and a periphery. The second side may face the inner wall of the handle 101. The periphery of the roller 107a may be smooth or rough. In one embodiment, the periphery includes a plurality of teeth that provide sufficient friction between the operator's thumb and the roller 107a to rotate the roller 107a.

[0044] The roller 107a has a roller hole 'h1' in the form of a through hole extending from the first side a1 to the second side a1 along an axis 'y' perpendicular to the longitudinal axis x'. The roller hole 'h1' can be located at the center of the roller 107a or offset from the center of the roller 107a. In one embodiment, the roller hole 'h1' is centrally located. The roller hole 'h1' is of a predetermined shape, such as, without limitation, circular, square, rectangular, spherical, etc. In one exemplary embodiment, the roller hole 'h1' is circular in shape.

[0045] The base plate 107b is disposed on the roller 107a on the first side a1. The base plate 107b may be coupled / connected to the roller 107a via a temporary / permanent coupling. Alternatively, the base plate 107b and the roller 107a may be manufactured as a unitary structure. In one exemplary embodiment, as shown in FIG. 2A, the roller 107a and the base plate 107b are manufactured integrally to form a single unit in the form of the intended structure. Forming the roller 107a and the base plate 107b as a single unit prevents wear, thereby increasing the durability of the delivery system 100.

[0046] Base plate 107b may be made of the same or different material as roller 107a. In one embodiment, base plate 107b and roller 107a are both made of ABS. Base plate 107b may include any predetermined shape, such as, without limitation, circular, spherical, elliptical, polygonal, etc. In one exemplary embodiment, base plate 107b is circular in shape.

[0047] The base plate 107b includes a predetermined diameter and thickness. The diameter of the base plate 107b may be equal to or less than the diameter of the rollers 107a. In an exemplary embodiment, the diameter of the base plate 107b is smaller than the diameter of the rollers 107a. Furthermore, the thickness of the base plate 107b may be the same as or different from the thickness of the rollers 107a.

[0048] As shown in FIG. 2A, the base plate 107b is provided with a first base hole 'h2' and a tubular means 'h3'. In one embodiment, the first base hole 'h2' is centrally located and the tubular means 'h3' is eccentrically located on the base plate 107b. The first base hole 'h2' can be located such that the first base hole 'h2' coincides with the roller hole 'h1' in such a way that the axis of both holes 'h1' and 'h2' is the same, i.e., axis 'y'. The first base hole 'h2' includes a larger diameter than the roller hole 'h1'. Such dimensions aid in coupling the roller assembly 107 to the handle 101 (described in detail below).

[0049] As shown in Figure 2A, tubular means 'h3' may be in the form of a hollow protrusion extending away from base plate 107b. Tubular means 'h3' extends from base plate 107b and forms an angle with respect to base plate 107b ranging from 0 to 180 degrees. In one exemplary embodiment, tubular means 'h3' is perpendicular to base plate 107b.

[0050] The tubular means 'h3' may be offset from the center of the base plate 107b. In one embodiment shown in Figure 2A, the tubular means 'h3' is eccentrically positioned adjacent to the first base hole 'h2' toward the periphery of the base plate 107b. The above-described structure and positioning of the tubular means 'h3' helps to establish a strong connection between the connecting shaft 107c and the base plate 107b.

[0051] The size and shape of the tubular means 'h3' may depend on the size and shape of the connecting shaft 107c.

[0052] The connecting shaft 107c may be operatively coupled to the roller 107a via a tubular means 'h3' of the base plate 107b. The connecting shaft 107c is made of a predetermined material. The predetermined material may include, without limitation, ABS, polycarbonate, etc. In an exemplary embodiment, the connecting shaft 107c is made of ABS.

[0053] An exemplary configuration of the connecting shaft 107c in the form of a box-end wrench is shown in Figure 2B, however, other configurations of the connecting shaft 107c capable of facilitating similar coupling and operation are within the scope of the present invention.

[0054] The connecting shaft 107c includes a proximal end 107c1 and a distal end 107c2. A first axial hole 'h4' can be disposed toward the proximal end 107c1, while the distal end 107c2 includes a second axial hole 'h5'. Thus, the first axial hole 'h4' and the second axial hole 'h5' are spaced apart from each other.

[0055] In one embodiment, the first axial bore 'h4' is configured to operatively receive the tubular means 'h3'. Accordingly, the diameter of the first axial bore 'h4' is slightly larger than the diameter of the tubular means 'h3'. In one embodiment, once the first axial bore 'h4' is secured onto the tubular means 'h3', the connection can be locked by a locking means. The locking means can include, without limitation, a locking pin, a rivet, or the like. In one exemplary embodiment, the locking means is a locking pin 'p', as seen in Figures 2 and 2D.

[0056] The second shaft hole 'h5' of the connecting shaft 107c may be movably coupled to the slider block 107d, and therefore the shape and size of the second shaft hole 'h5' may depend on the shape and size of the slider block 107d.

[0057] An exemplary structure of slider block 107d is shown in Figure 2C. As is apparent from the exemplary depiction of Figure 2C, slider block 107d is in the form of a generally rectangular shaped block 107d1 having legs 107d2 and a cavity 107d3 extending from a proximal end 'd1' to a distal end 'd2' of block 107d1. While the present invention has been described with the structured slider block 107d described above, it should be noted that other structures of slider block 107d that provide equivalent coupling and operation of roller assembly 107 are within the scope of the present invention.

[0058] The leg 107d2 can extend from the proximal end d1 of the block 107d1. In one embodiment, the leg 107d2 extends away from the block 107d1 in a manner such that the leg 107d2 is perpendicular to the block 107d1 and the longitudinal axis x'. Alternatively, the leg 107d2 can be angled relative to the block 107d1 at an angle other than 90 degrees.

[0059] The leg 107d2 may include a predetermined shape and dimensions. For example, the leg 107d2 may be a cylindrical structure having a predetermined length and diameter. The length of the leg 107d2 may be equivalent to the depth of the second axial hole 'h5'. In one embodiment, the diameter of the leg 107d2 is slightly smaller than the diameter of the second axial hole 'h5', thereby allowing the leg 107d2 to be operably received in the second axial hole 'h5'. Optionally, the connection between the leg 107d2 and the second axial hole 'h5' may be reinforced by a locking means, such as a locking pin, rivet, or the like.

[0060] As seen in Figure 2C, cavity 107d3 extends from distal end d2 to proximal end 'd1' of block 107d1. Cavity 107d3 receives inner tube 20 at proximal end 'd1' of block 107d1. Thus, inner tube 20 extending from luer hub 10 passes through slider block 107d and terminates near distal end 101c of handle 101, thereby supporting slider block 107d (as shown in Figure 1A).

[0061] Cavity 107d3 also receives hypotube 105 at the distal end 'd2' of block 107d1. Accordingly, the shape and dimensions of cavity 107d3 depend on the shape and dimensions of hypotube 105. In one exemplary embodiment, cavity 107d3 is circular in shape to accommodate hypotube 105 and inner tube 20, both of which have circular cross sections. The diameter of cavity 107d3 is selected to be complementary to the inner diameter of hypotube 105, such that hypotube 105 is securely received within cavity 107d3 at distal end d2 of block 107d1. In one embodiment, cavity 107d3 includes a uniform diameter slightly larger than hypotube 105, such that hypotube 105 and inner tube 20 are coaxially received within cavity 107d3.

[0062] Such an arrangement of the inner tube 20, slider block 107d, and hypotube 105 allows for controlled movement of the hypotube 105 along the longitudinal axis 'x' of the delivery system 100 over the inner tube 20 as the rollers 107a rotate. Thus, as the rollers 107a rotate, the slider block 107d is configured to translate the rotational movement of the roller assembly 107 into forward and rearward movement of the hypotube 105 along the longitudinal axis 'x' on the inner tube 20 relative to the outer sheath 103 (described in more detail below).

[0063] The above-mentioned components of roller assembly 107 are disposed within a cavity in handle 101 and are coupled to handle 101 with the aid of coupling means. In one exemplary embodiment, as shown in Figure 3, roller assembly 107 is rotatably coupled to handle 101 via set screw 109. However, the use of other coupling means is within the scope of the present invention.

[0064] The set screw 109 can be inserted through the roller 107a and base plate 107b and secured to the inner wall of the handle 101. An enlarged view of the set screw 109 is shown in FIG. 3. As can be seen, the set screw 109 includes a shaft 's' with a threaded tip 't' and a head 'h'. In one embodiment, the head 'h' is wider than the shaft 's'. The dimensions of the set screw 109 can depend on the dimensions of the roller hole 'h1' and the first base hole 'h2'. For example, the diameter of the shaft 's' can be smaller than the diameters of the roller hole 'h1' and the first base hole 'h2'. The length of the shaft 's' can be longer than the depth of the roller hole 'h1', allowing the shaft 's' to pass through the roller hole 'h1' and the first base hole 'h2'. The diameter of the head 'h' can be larger than the diameter of the roller hole 'h1' but slightly smaller than the diameter of the first base hole 'h2'.

[0065] Thus, the shaft 's' of the fixing screw passes first through the first base hole 'h2' and then through the roller hole 'h1', while the head 'h' is fixed within the first base hole 'h2' due to the selected dimensions. The threaded tip 't' is then screwed into the handle 101 from the inside, thereby connecting the roller assembly 107 to the handle 101.

[0066] 1A-2, the hypotube 105 includes a proximal end 105b and a distal end 105c. The hypotube 105 extends along a longitudinal axis 'x' from the cavity 107d3 (proximal end 105b) of the slider block 107d to the distal end 100b (distal end 105c) of the delivery system 100. Thus, the proximal end 105b of the hypotube 105 is received within the cavity 107d3 of the slider block 107d. In one embodiment, the hypotube 105 is fixedly coupled to the inner diameter of the cavity 107d3 of the slider block 107d. The inner diameter of the hypotube 105 is greater than the outer diameter of the inner tube 20. The inner diameter of the hypotube 105 therefore coaxially receives the inner tube 20, causing the hypotube 105 to move (reciprocate) along the longitudinal axis 'x' over the inner tube 20 relative to the outer sheath 103. Thus, whenever the hypotube 105 moves forward or backward, it is always supported by the inner tube 20.

[0067] The stent to be delivered is enclosed in an outer sheath 103 and pre-loaded in a crimped state onto a hypotube 105 towards the distal end 100 b of the delivery system 100 .

[0068] A soft tip 105a is provided at the distal end 105c of the hypotube 105. The soft tip 105a defines the distal end 100b of the delivery system 100. The soft tip 105a facilitates atraumatic advancement of the delivery system 100 within a patient's body. In one embodiment, the soft tip 105a is attached onto a PEEK tube, which is further attached onto the hypotube 105.

[0069] A stent driver 105d is provided toward the distal end 105c of the hypotube 105 for pushing the stent during deployment. The stent driver 105d may be positioned a predetermined distance from the distal end 100b of the delivery system 100. In some embodiments, the predetermined distance may range from 10mm to 50mm.

[0070] The stent driver 105d is attached to a portion of the circumference of the hypotube 105 by an attachment means. The attachment means can be a temporary attachment or a permanent attachment. In one exemplary embodiment, the stent driver 105d is permanently attached to the hypotube 105 by welding.

[0071] Stent driver 105d may be constructed from a predetermined material, which may include, without limitation, stainless steel, nitinol, etc. In one exemplary embodiment, stent driver 105d is laser cut from nitinol tubing.

[0072] The stent driver 105d may include a predetermined structure having a stent engagement means and a coupling portion. The stent engagement means may assist in retaining the stent by temporarily engaging a set of cross-over nodes present on the braided stent. The coupling portion may assist in coupling the stent driver 105d to the hypotube 105. One exemplary embodiment of the stent driver 105d is shown in FIG. 4. The stent driver 105d shown in FIG. 4 is a two-prong fork type structure having a coupling portion in the form of a stem portion 5d1 and a stent engagement means in the form of a pair of prong portions 5d2. In one exemplary embodiment, the stem portion 5d1 is coupled to the hypotube 105, while the prong portions 5d2 do not contact the hypotube 105. The stent driver 105d is positioned over the hypotube 105 such that the prong portions 5d2 face toward the distal end 100b of the delivery system 100. The stem portion 5d1 of the stent driver 105d includes a plurality of stem holes 5d3. In one embodiment, the stem portion 5d1 includes three stem holes 5d3. The stem holes 5d3 aid in welding the stent driver 105d onto the hypotube 105.

[0073] The prongs 5d2 of the stent driver 105d are raised relative to and extend away from the stem 5d1, and such a configuration of the prongs 5d2 helps to retain the stent by temporarily engaging a set of crossing nodes present in the braided stent (described in more detail below).

[0074] The delivery system 100 described above, with the aid of the roller assembly 107, can easily deploy the stent at the target site.

[0075] As mentioned above and shown in Figure 5, the delivery system 100 loaded with the crimped stent is packaged as an assembly. The outer sheath 103 covers the hypotube 105 such that the stent remains completely covered by the outer sheath 103, with only the soft tip 105a exposed, as shown in Figure 5.

[0076] Further, as seen in the exemplary embodiment of Figure 5A, the stent 200 is mounted such that the stent driver 105d contacts the stent 200 at predetermined locations. In one embodiment, the prongs 5d2 of the stent driver 105d hold the stent 200 by engaging with respective crossing nodes located at the proximal portion of the stent 200 (located towards the proximal end of the stent), as more clearly shown in Figure 5A.

[0077] It should be noted that roller 107a may be locked to prevent accidental rotation of roller 107a when delivery system 100 is not in use, i.e., when delivery system 100 is packaged or prior to deployment. In one embodiment, roller 107a may be locked by locking pin 30, as shown in FIG. 6. Locking pin 30 may be removably attached to roller 107a.

[0078] The lock pin 30 may be in the form of a cylindrical rod, as shown in FIG. 6. However, other structural embodiments of the lock pin 30 having equivalent functionality are within the scope of the present invention. The roller 107a in this embodiment may include a through lock hole to allow passage of the lock pin 30 through the roller 107a. The through hole may be shaped and sized according to the shape and dimensions of the lock pin 30.

[0079] The presence of the lock pin 30 limits the rotation of the roller 107a.

[0080] The delivery system 100 described above operates in a predetermined manner to deploy the stent 200. Figure 7 shows an exemplary embodiment of the mechanism of operation of the delivery system 100 and the steps followed to deploy the stent 200 at the target site.

[0081] During the deployment procedure, the stent 200 pre-loaded on the hypotube 105 is advanced through the patient to the target site. Once at the target site, the locking pin 30 is removed in step 701, thereby allowing the roller 107a to rotate freely.

[0082] In step 703, the roller 107a is rotated clockwise or counterclockwise by the operator. Note that both clockwise and counterclockwise rotation of the roller 107a produces the same result. Therefore, regardless of the direction of rotation, the mechanism of operation of the delivery system 100 to deploy the stent 200 remains the same.

[0083] As described above, the roller 107a is capable of 360-degree rotation. In a complete 360-degree rotation cycle, regardless of the direction of rotation of the roller 107a, the hypotube 105 first moves forward, followed by a rearward movement along the longitudinal axis of the delivery system 100. Each 360-degree rotation cycle (rotation cycle) includes two half-cycles: a first half-cycle of rotation and a second half-cycle of rotation, each of 180 degrees (clockwise or counterclockwise).

[0084] Note that during the first half-cycle of rotation, the hypotube 105 is configured to move forward and the stent engagement means is configured to engage a set of cross nodes on the stent 200. The set of cross nodes in each rotation is located toward the proximal end 100a of the delivery system 100 compared to the previous rotation. Thus, during every first half-cycle of rotation, the hypotube 105 moves forward to facilitate engagement of the stent engagement means with a new set of cross nodes that are located closer to the proximal end 100a than the previous set of cross nodes.

[0085] In the second half cycle of rotation, the hypotube 105 moves rearward, causing the stent engagement means to disengage from a set of crossing nodes on the stent 200 .

[0086] The number of rotational cycles varies depending on the length of the stent 200. For illustrative purposes, the following method will be described in terms of two 360 degree rotations: a first rotational cycle of 360 degrees and a second rotational cycle of 360 degrees.

[0087] In step 705, upon completion of the first half cycle (180 degree rotation) of the first rotational cycle (360 degree rotation) of roller 107a, roller 107a and connecting shaft 107c are operatively coupled to one another, causing a simultaneous 180 degree rotation of connecting shaft 107c, as shown in Figure 8A. In one embodiment, connecting shaft 107c rotates in the same direction as roller 107a rotation.

[0088] The rotational motion of roller assembly 107 is translated into translation of hypotube 105 along longitudinal axis 'x' by slider block 107d. At this stage, hypotube 105 moves forward relative to outer sheath 103, as shown in Figure 8B. Note that during the forward translation of hypotube 105, prongs 5d2 remain engaged with a set of crossing nodes on stent 200.

[0089] The forward movement of the hypotube 105 exposes at least a distal portion of the stent 200 as shown in Figure 8B. The portion of the stent 200 exposed by the outer sheath 103 instantly expands while the remaining portion (if present) remains in a contracted state covered by the outer sheath 103. The same can be seen in Figure 8B.

[0090] As soon as the stent 200 is expanded, the prongs 5d2 of the stent driver 105d engage and disengage a set of crossing nodes of the stent 200.

[0091] In step 707, roller 107a is further rotated to complete a second half cycle (180 degree rotation) of the first rotational cycle. The rotation of roller 107a causes a simultaneous 180 degree rotation of connecting shaft 107c when roller 107a is operatively coupled to connecting shaft 107c, as shown in FIG. 8C. The rotational motion of roller assembly 107 is translated into movement of hypotube 105 along longitudinal axis 'x' by slider block 107d. At this stage, hypotube 105 moves rearward relative to outer sheath 103. In one embodiment, hypotube 105 moves rearward, traveling a first distance. Thus, one complete rotational cycle results in zero displacement of hypotube 105 relative to its original position.

[0092] Note that given that prong portion 5d2 has already been disengaged from stent 200, upon reaching the end of step 705, stent 200 maintains its position and does not move backward with hypotube 105 as hypotube 105 moves backward, as shown in FIG. 8D.

[0093] In step 709, roller 107a is rotated to complete the first half cycle (180 degree rotation) of the second rotation cycle (360 degree rotation). In this step, hypotube 105 moves forward relative to outer sheath 103. During the forward movement of hypotube 105, and prior to traveling the first distance, stent driver 105d contacts the proximal portion of stent 200 in its crimped state, which is still covered by outer sheath 103. At this stage, prongs 5d2 engage a new set of cross nodes present on the proximal portion of stent 200 in its crimped state.

[0094] Note that whenever the hypotube 105 moves forward, the prongs 5d2 engage a new set of crossing nodes, with each new set of crossing nodes being positioned more proximal to the proximal end of the stent 200 (and similarly the proximal end 100a of the delivery system 100) than the previous set of crossing nodes. The following table provides an exemplary table illustrating the foregoing: [Table 1]

[0095] After engagement of the prong portion 5d2 and the cross node, the stent driver 105d further pushes the stent 200 to complete expansion until the hypotube 105 has advanced a first distance (i.e., until the first half-cycle of the second rotational cycle is completed).

[0096] In step 711, roller 107a is rotated to complete a second half cycle (180 degree rotation) of the second rotational cycle. In this step, hypotube 105 moves rearward relative to outer sheath 103. Once prong portion 5d2 disengages from stent 200, hypotube 105 moves rearward without affecting stent 200, similar to step 707.

[0097] Note that depending on the length of the stent 200, the roller 107a is rotated multiple times (clockwise / counterclockwise) in the same manner as detailed above in steps 703-711 to push the stent 200 out of the outer sheath 103 until the stent 200 is fully expanded in step 713. For example, the number of rotational cycles required for a short stent (20 mm-40 mm) may be fewer than for a medium length stent (60 mm-80 mm) and a long stent (100 mm-250 mm). In one exemplary embodiment, a stent 200 having a length of 150 mm requires 38 rotational cycles for its deployment.

[0098] In step 713 , the stent 200 expands to its deployed diameter at the target site, and the delivery system 100 is then withdrawn in step 715 .

[0099] Deployment of the stent 200 using the delivery system 100 via the roller assembly 107 is simple and error-free. As described above, rotation of the rollers 107a automatically causes movement of the linkage shaft 107c, which in turn causes movement of the hypotube 105 along the longitudinal axis 'x' to deploy the stent 200 at the target site.

[0100] The delivery system 100 of the present invention described above is associated with the following advantages. 1. Single-Handed Operation: The delivery system 100 of the present invention can be operated using one hand, unlike conventional delivery systems that require the simultaneous use of both hands of the operator. Single-handed operation of the delivery system 100 eliminates any potential errors caused by the synchronization of both hands by the operator, thereby facilitating error-free delivery and easy deployment of the stent 200. The delivery system 100 of the present invention significantly reduces the operator's effort, as is evident from the foregoing description. 2. Procedure Time: Additionally, the use of the roller assembly 107 of the present invention reduces overall procedure time. Also, with the use of the roller assembly 107 of the present invention, delivery of long stents can be performed with minimal effort and minimal procedure time as opposed to conventional delivery systems. 3. Application of mind: The roller assembly 107 is very user-friendly and does not require any special application of mind, as the only effort required by the operator is to rotate the rollers 107a. Such a feature of the present invention further reduces the possibility of error and improper deployment of the stent 200. 4. Training: Considering that the operation of the delivery system 100 requires only the rotation of the roller 107a without any consideration or special care, no dedicated preparation or training is required to be undertaken by the operator (physician), who can immediately use the delivery system 100 for the deployment of the stent 200. Thus, the delivery system 100 of the present invention is easy to handle and operate, and allows for delivery of the stent in a controlled manner.

[0101] The scope of the present invention is limited only by the appended claims. More generally, those skilled in the art will readily recognize that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the particular application or applications in which the teachings of the present invention are used.

Claims

1. A delivery system (100) for delivering a self-expanding braided stent (200), comprising: a handle (101) forming a housing, the handle (101) having a distal end (101c); a roller assembly (107) disposed within the housing and rotatably coupled to the handle (101), a rotatable roller (107a) having a roller hole ('h1'); a base plate (107b) connected to or integral with said roller (107a), said base plate (107b) having a first base hole ('h2') and a tubular means ('h3'), said first base hole ('h2') coinciding with said roller hole ('h1'); a connecting shaft (107c) having a first axial bore ('h4') and a second axial bore ('h5'), said first axial bore ('h4') operatively receiving said tubular means ('h3'); and a slider block (107d) including a block (107d1) and a leg (107d2), wherein the block (107d1) has a cavity (107d3) extending from a proximal end ('d1') to a distal end ('d2') of the block (107d1), and the leg (107d2) extends away from the proximal end ('d1') of the block (107d1) and is operatively received in the second axial hole ('h5'); a roller assembly (107) including: an inner tube (20) extending from the luer hub (10) through the cavity (107d3) from the proximal end ('d1') and terminating near the distal end (101c) along the longitudinal axis ('x') of the delivery system (100); a hypotube (105) fixedly received within the cavity (107d3) from the distal end (d2) of the block (107d1) and coaxially receiving the inner tube (20), the hypotube (105) being attached toward the distal end (100b) of the delivery system (100) together with a self-expandable braided stent (200) in a crimped state; an outer sheath (103) disposed over the hypotube (105) to cover the self-expandable braided stent (200); and The delivery system (100) is configured such that, as the roller (107a) rotates, the slider block (107d) translates the rotational movement of the roller assembly (107) into forward and backward movement of the hypotube (105) over the inner tube 20 relative to the outer sheath (103) along the longitudinal axis 'x'.

2. The delivery system (100) for delivering a self-expandable braided stent (200) according to claim 1, wherein said self-expandable braided stent (200) comprises a length in the range of 20 mm to 250 mm.

3. 10. The delivery system (100) for delivering a self-expandable braided stent (200) of claim 1, wherein the roller (107a) includes a plurality of teeth on its periphery.

4. 10. The delivery system (100) for delivering a self-expandable braided stent (200) of claim 1, wherein the distal end (100b) comprises a soft tip (105a).

5. A delivery system (100) for delivering a self-expandable braided stent (200) as described in claim 1, wherein the roller assembly (107) is rotatably coupled to the inner wall of the handle (101) via a fixing screw (109) passing through the roller hole 'h1' and the first base hole 'h2'.

6. 2. A delivery system (100) for delivering a self-expandable braided stent (200) as described in claim 1, wherein the roller (107a) is locked by a removable locking pin (30) that limits accidental rotation of the roller (107a) when the delivery system (100) is not in use.

7. 2. The delivery system (100) for delivering a self-expandable braided stent (200) of claim 1, wherein the cavity (107d3) comprises a uniform diameter that complements the inner diameter of the hypotube (105).

8. 2. A delivery system (100) for delivering a self-expandable braided stent (200) as described in claim 1, wherein the hypotube (105) comprises a stent driver (105d), the stent driver (105d) including stent engagement means for temporarily engaging a set of crossing nodes of the self-expandable braided stent (200).

9. 2. A delivery system (100) for delivering a self-expanding braided stent (200) as described in claim 1, wherein the roller (107a) is rotated multiple times in either a clockwise or counterclockwise direction depending on the length of the self-expanding braided stent (200), thereby pushing the self-expanding braided stent (200) out of the outer sheath (103).

10. 2. A delivery system (100) for delivering a self-expandable braided stent (200) as described in claim 1, wherein each rotation of the roller (107a) includes a first half cycle of rotation and a second half cycle of rotation, each of 180 degrees in a clockwise or counterclockwise direction.

11. 10. A delivery system (100) for delivering a self-expandable braided stent (200) as described in claims 1 and 9, wherein in the first half-cycle of rotation, the hypotube (105) is configured to move forward, and the stent engagement means is configured to engage with the set of crossing nodes of the self-expandable braided stent (200) so that the set of crossing nodes engaged in each rotation is closer to the proximal end (100a) of the delivery system (100) relative to the set of crossing nodes in the previous rotation.

12. A delivery system (100) for delivering a self-expandable braided stent (200) as described in claims 1 and 9, wherein in the second half-cycle of rotation, the hypotube (105) is configured to move backward and the stent engagement means is configured to engage and disengage with the set of crossing nodes of the self-expandable braided stent (200).

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