1. A delivery device (100) for deploying a stent within a body lumen, the delivery device (100) comprising: a. a shaft (103) extending between a proximal end (103a) and a distal end (103b) of the shaft (103); b. a gripper assembly (110) disposed at the distal end (103b) of the shaft (103), the gripper assembly (110) comprises: i. a hub (111) coupled to the distal end (103b) of the shaft (103) and having a plurality of coupling elements (111b); ii. a plurality of connecting members (113) pivotally coupled to the hub (111), each connecting member (113) comprises: a. a first connecting member (113a) having a first end (113a-1) pivotally coupled to a respective coupling element (111b) of the hub (111) and a second end (113a-2); b. a second connecting member (113b) having a first end (113b-1) pivotally coupled to the second end (113a-2) of the first connecting member (113a) and a second end (113b-2); and iii. a plurality of gripping pads (115), each gripping pad (115) pivotally coupled to the second end (113b-2) of a corresponding second connecting member (113b) and configured to engage with the stent; and c. an actuation assembly (131) coupled to the connecting members (113), and configured to actuate the connecting members (113) to toggle the gripping pads (115) between an open configuration and a closed configuration.

2. The delivery device (100) as claimed in claim 1, wherein the actuation assembly (131) comprises: a. an actuator (133) slidably disposed at the proximal end (103a) of the shaft (103); and b. a plurality of anchor wires (135) extending longitudinally along the shaft (103), each anchor wire (135) having a proximal end (135a) coupled to the actuator (133) and a distal end (135b) coupled to a corresponding connecting member (113) via a coupling member (119).

3. The delivery device (100) as claimed in claim 2, wherein the coupling member (119) comprises: a. a first end (119a) coupled to a distal end (135b) of the corresponding anchor wire (135); and b. a second end (119b) coupled to a junction between the first connecting member (113a) and the second coupling member (113b) of the corresponding connecting member (113); and c. wherein the coupling member (119) is configured to transmit a tensile force from the corresponding anchor wire (135) to the connecting member (113).

4. The delivery device (100) as claimed in claim 1, wherein the delivery device (100) comprises a sheath (105) including: a. a lumen (106) extending longitudinally between a proximal end (105a) and a distal end (105b) of the sheath (105); and b. a plurality of slots (109) formed through a wall of the sheath (105) at the distal end thereof, each slot (109) being configured to allow at least a portion of a corresponding second end (113b-2) of the second connecting member (113b) to extend outwardly through the slot (109).

5. The delivery device (100) as claimed in claim 4, wherein the delivery device (100) comprises a retainer ring (107) disposed on an outer surface of the sheath (105) at the distal end (105b) thereof, and configured to retain the stent relative to the sheath (105).

6. The delivery device (100) as claimed in claim 4, wherein the delivery device (100) comprises a handle (130) coupled to the proximal end (105a) of the sheath (105), the handle (130) comprises: a. a longitudinal slot (134) disposed on a wall of the handle (130) and configured to receive a portion of the actuator (133) and allow longitudinal movement of the actuator (133) between a first position and a second position; and b. a circumferential groove (136) disposed on an outer surface of the handle (130) at a proximal end of the longitudinal slot (134), and configured to receive a lock ring (139) of the delivery device (100) and allow rotation about a longitudinal axis of the handle (130).

7. The delivery device (100) as claimed in claim 6, wherein the lock ring (139) is disposed within the circumferential groove (136) of the handle (130), the lock ring (139) being configured to retain the actuator (133) in a locked position.

8. The delivery device (100) as claimed in claim 7, wherein the lock ring (139) comprises a slot (140) configured to permit movement of the actuator (133) along the slot (140) when the lock ring (139) is aligned with the longitudinal slot (134) of the handle (130).

9. The delivery device (100) as claimed in claim 1, wherein the delivery device (100) comprises a resilient member (121) disposed at a respective connecting member (113), the resilient member (121) configured to exert a biasing force to retain the gripping pad (115) in the open configuration.

10. The delivery device (100) as claimed in claim 9, wherein the resilient member (121) is formed from one or more biocompatible materials, including stainless steel, cobalt-chromium alloys, polymeric elastomers, shape memory alloys, or any one or combination thereof.

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

1. TITLE OF THE INVENTION:
DELIVERY DEVICE FOR DEPLOYING A STENT

2. APPLICANT:
Name : Meril Corporation (I) Private Limited
Nationality : Indian
Address : Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad - 396191, Gujarat, India

3. PREAMBLE TO THE DESCRIPTION
The following specification particularly describes the invention and the manner in which it is to be performed:
FIELD OF INVENTION
[001] The present disclosure relates to a delivery device. More specifically, the present disclosure pertains to a delivery device for deploying a stent.
BACKGROUND OF INVENTION
[002] A stent is an expandable mesh tube structure inserted into the lumen of an anatomical vessel to maintain, open, or dilate tubular anatomical structures. The stent (self- expanding stent) is delivered through the body lumen on a catheter to the treatment site, where the stent is released from the catheter, allowing the stent to automatically expand and come into direct contact with the luminal wall of the vessel.
[003] The conventional delivery device generally employs a tube, a sheath, and a handle for the deployment of the stent. However, the conventional delivery device exhibits limitations in terms of design and operational smoothness. For example, in the case of conventional devices, the practitioner needs to hold components steady and, at the same time, manipulate other components for the deployment of the stent. Any irregular movement by the practitioner results in the premature deployment of the stent. Furthermore, the conventional delivery device fails to provide adjustment in case of mispositioning of the stent within the catheter. A different procedure is required for the realignment of the stent. This makes the procedure both time-consuming and costly.
[004] Thus, there is a need for a delivery device that overcomes the limitations and drawbacks associated with the conventional delivery device.
OBJECTS OF INVENTION
[005] An object of the present disclosure is to provide a delivery device that is configured to deploy the stent at a desired location.
[006] Another object of the present disclosure is to provide a delivery device that is configured to prevent premature or unintended deployment of the stent.
[007] Another object of the present disclosure is to provide a delivery device that is configured to improve implantation accuracy.
[008] Yet another object of the present disclosure is to provide a delivery device that is configured to reduce procedural time.
SUMMARY OF INVENTION
[009] 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.
[0010] The present disclosure relates to a delivery device for deploying a stent within a body lumen. The delivery device includes a shaft extending between a proximal end and a distal end thereof and a gripper assembly disposed at a distal end of the shaft. The gripper assembly includes a hub coupled to the distal end of the shaft, having a plurality of coupling elements. The gripper assembly includes a plurality of connecting members. Each connecting member includes a first connecting member and a second connecting member. The first connecting member includes a first end pivotally coupled to a respective coupling element of the hub and a second end. The second connecting member includes a first end pivotally coupled to the second end of the first connecting member and a second end. Further, the gripper assembly includes a plurality of gripping pads, each gripping pad pivotally coupled to the second end of a corresponding second connecting member. Each gripping pad is configured to engage with the stent. Further, the delivery device includes an actuation assembly coupled to the connecting members and configured to actuate the connecting members to toggle the gripping pads between an open configuration and a closed configuration.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[0012] Fig. 1A depicts a perspective view of a delivery device 100, according to an embodiment of the present disclosure.
[0013] Fig. 1B depicts an exploded view of the delivery device 100, according to an embodiment of the present disclosure
[0014] Fig. 1C depicts a cross-sectional view of the delivery device 100, according to an embodiment of the present disclosure.
[0015] Fig. 1D depicts an enlarged cross-sectional view of a distal portion of the delivery device 100, according to an embodiment of the present disclosure.
[0016] Fig. 1E depicts an enlarged cross-sectional view of a proximal portion of the delivery device 100, according to an embodiment of the present disclosure.
[0017] Fig. 2 depicts a perspective view of a handle 130 of the delivery device 100 according to an embodiment of the present disclosure.
[0018] Fig. 3 depicts a perspective view of a sheath 105 of the delivery device 100, according to an embodiment of the present disclosure.
[0019] Fig. 4 depicts a perspective view of a shaft 103 of the delivery device 100, according to an embodiment of the present disclosure.
[0020] Fig. 5 depicts a perspective view of a gripper assembly 110 of the delivery device 100, according to an embodiment of the present disclosure.
[0021] Fig. 5A depicts a perspective view of a hub 111 of the gripper assembly 110, according to an embodiment of the present disclosure.
[0022] Fig. 5B depicts a perspective view of a connecting member 113 of the gripper assembly 110, according to an embodiment of the present disclosure.
[0023] Fig. 5C depicts a perspective view of a gripping pad 115 of the assembly 110, according to an embodiment of the present disclosure.
[0024] Fig. 5D depicts a perspective view of a coupling member 119 of the gripper assembly 110, according to an embodiment of the present disclosure
[0025] Fig. 6 depicts a perspective view of an actuation assembly 131 of the delivery device 100, according to an embodiment of the present disclosure.
[0026] Fig. 6A depicts a perspective view of an actuator 133 of the actuation assembly 131, according to an embodiment of the present disclosure.
[0027] Fig. 7 depicts a perspective view of a lock ring 139 of the delivery device 100, according to an embodiment of the present disclosure.
[0028] Fig. 8A and 8B illustrate a sequence depicting the deployment a stent 802 using the delivery device 100, according to an embodiment of the present disclosure.
[0029] Fig. 8C and 8D illustrate another sequence depicting the deployment of the stent 802 using the delivery device 100, according to another embodiment of the present disclosure.
[0030] Fig. 9 depicts a flowchart of a method 800 for deploying a stent 802 within a body lumen 806 using the delivery device 100, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF ACCOMPANYING DRAWINGS
[0031] 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.
[0032] 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.
[0033] 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.
[0034] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[0035] The present disclosure relates to a delivery device (hereinafter, device) for deployment of a stent within the anatomical vessel of the patient. The device is configured to deploy the stent at a desired position with minimal procedure timing. The device is configured to prevent premature deployment of the stent. In particular, the device includes a gripper assembly that is configured to hold the stent in a crimped state between a sheath of the device and a catheter, thereby preventing the stent from premature deployment. The device includes an actuation assembly configured to actuate the gripper assembly between closed and open states. Once optimal positioning of the device is achieved, the actuation assembly is operable to retract the gripper assembly in the closed state in a controlled manner for easy deployment of the stent at the desired position, thereby reducing the procedural complexity and operational inconsistencies. Overall, the device reduces the chance of premature deployment and improves implantation accuracy. The device also reduces procedural time and improves the loading of the stent in the device.
[0036] Figs. 1A, 1B, 1C, 1D and1E depict various views of a delivery device 100, according to an embodiment of the present disclosure. The delivery device 100 (hereinafter referred to as “the device 100”) is configured to deploy a stent within a body lumen of a patient. The device 100 is configured for accurate positioning and reliable release of the stent at a target treatment site while maintaining stability during the deployment procedure. In an embodiment, the device 100 extends longitudinally between a proximal end 100a and a distal end 100b. The proximal end 100a generally corresponds to the end of the device that remains outside the patient and is manipulated by a clinician during the procedure. The distal end 100b corresponds to the end that is advanced into the body lumen to reach the treatment site. The proximal and distal references are used throughout the present disclosure to describe the orientation and relative positioning of the various components of the device 100. In an embodiment, the device 100 includes a shaft 103, a sheath 105, a gripper assembly 110 (shown in Fig. 1D), a handle 130, and an actuation assembly 131 (shown in Fig. 1E). The shaft 103 extends along the longitudinal axis of the device 100 and provides structural support and a pathway for the transmission of mechanical forces between the handle 130 and the distal components of the device 100. The sheath 105 is disposed at least partially around the shaft 103. The gripper assembly 110 is positioned toward the distal end 100b of the device 100 and is configured to securely engage and hold the stent during advancement of the device 100 through the body lumen. The gripper assembly 110 may cooperate with the sheath 105 to maintain the stent in a controlled position until deployment is initiated.
[0037] Fig. 2 depicts a perspective view of the handle 130, according to an embodiment of the present disclosure. The handle 130 is disposed at the proximal end 100a of the device 100. The handle 130 is configured to be manually held and operated by a user during use of the device 100. The handle 130 functions as a structural housing for internal components and as an interface through which actuating forces are applied to the actuation assembly 131. In an embodiment, the handle 130 is an elongated hollow body defining an internal cavity 132 extending along a longitudinal axis of the handle 130 between a proximal end 130a and a distal end 130b of the handle 130. The internal cavity 132 is configured to receive at least a portion of the shaft 103 and at least a portion of the actuation assembly 131. The handle 130 provides an enclosed passage that maintains alignment of the shaft 103 and actuation assembly 131.
[0038] The distal end 130b of the handle 130 is coupled to the sheath 105 such that the handle 130 remains stationary relative to the sheath 105 during operation, while the actuation assembly 131 is movable relative to the handle 130. The coupling between the handle 130 and the sheath 105 may be permanent or releasable and may be achieved through threaded engagement, interference fit, adhesive bonding, welding, or equivalent joining techniques. The handle 130 includes a longitudinal slot 134 disposed on a wall of the handle 130. The longitudinal slot 134 communicates with the internal cavity 132 of the handle 130 and is configured to receive a manually operable element of the actuation assembly 131. In an embodiment, the longitudinal slot 134 is configured to receive a portion of the actuator 133 and allow longitudinal movement of the actuator 133 between a first position and a second position. Further, the handle 130 includes a circumferential groove 136 formed on an outer surface of the wall of the handle 130 at a proximal end of the longitudinal slot 134. In an embodiment, the circumferential groove 136 is positioned to intersect or align with the longitudinal slot 134. The circumferential groove 136 is configured to receive a lock ring 139 of the device 100 and allow rotation about the longitudinal axis of the handle 130.
[0039] The handle 130 may include ergonomic contours, surface textures, or grip-enhancing features to facilitate secure handling. In an embodiment, the handle 130 provides a stable housing, guided actuation, and controlled locking functionality, enabling precise manipulation of the actuation assembly 131 and reliable operation of the device 100.
[0040] Fig. 3 depicts a perspective view of the sheath 105, according to an embodiment of the present disclosure. The sheath 105 is disposed towards the distal end 100b of the device 100. In an embodiment, the sheath 105 is an elongated tubular member extending along a longitudinal axis of the device 100 and defines an outer structural body configured to enclose and guide internal components of the device 100. In an embodiment, the sheath 105 includes a lumen 106 extending longitudinally between a proximal end 105a and a distal end 105b of the sheath 105. The lumen 106 is configured to accommodate at least a portion of the shaft 103 and a portion of the gripper assembly 110, while permitting relative axial movement of one or more of these components within the sheath 105. The lumen 106 maintains alignment of the internal components and provides a protected passage for actuation and deployment of the gripper assembly 110. The proximal end 105a of the sheath 105 is coupled to the handle 130, such that the sheath 105 remains substantially stationary relative to the handle 130 during operation. The distal end 105b of the sheath 105 defines an opening.
[0041] In an embodiment, the sheath 105 includes a plurality of slots 109 formed through a wall of the sheath 105 at the distal end thereof. The slots 109 are configured to receive and guide at least a portion of the gripper assembly 110 or associated linkage elements. During operation of the device 100, the gripper assembly 110 is selectively extendable outwardly through the slots 109 and retractable back into the lumen 106. The slots 109 allow controlled movement of the gripper assembly 110 relative to the sheath 105 while maintaining the positional constraint and alignment of the internal component. Further, the delivery device 100 includes a retainer ring 107 disposed on an outer surface of the sheath 105 at the distal end 105b, as depicted in Fig. 3. The retainer ring 107 is configured to retain the stent relative to the sheath 105. In an embodiment, the retainer ring 107 is configured to restrict or prevent proximal movement of the stent during manipulation, engagement, or retrieval by the gripper assembly 110. The retainer ring 107 may be formed as a protrusion, flange, collar, step, or equivalent structural feature on the sheath 105. In an embodiment, the retainer ring 107 is a collar.
[0042] Fig. 4 depicts a perspective view of the shaft 103, according to an embodiment of the present disclosure. The shaft 103 extends between a proximal end 103a and a distal end 103b of the shaft 103 and is at least partially received within the handle 130 and the sheath 105. In an embodiment, the proximal end 103a of the shaft 103 is coupled to the handle 130, and the distal end 103b of the shaft 103 is coupled to the gripper assembly 110 and a soft tip. The shaft 103 serves as a structural and functional support member of the device 100 and facilitates transmission of actuation forces between the handle 130 and the gripper assembly 110. The shaft 103 includes external threads disposed at the proximal end 103a thereof. In an embodiment, the shaft 103 defines a lumen extending between the proximal end 103a and the distal end 103b. The lumen is configured to provide a passage to a guidewire (not shown), thereby enabling tracking and positioning of the device 100 within the body lumen.
[0043] Fig. 5 depicts a perspective view of the gripper assembly 110, according to an embodiment of the present disclosure. The gripper assembly 110 is disposed at the distal end 103b of the shaft 103 and configured to selectively secure and release the stent. The gripper assembly 110 includes a hub 111, a plurality of connecting members 113, a plurality of gripping pads 115, a plurality of coupling members 119, and a plurality of resilient members 121. For ease of explanation, although the gripper assembly 110 includes multiple sets of connecting members 113, the gripping pads 115, the coupling members 119, and the resilient members 121, only one such set is described in detail herein. It shall be understood that the remaining sets are identical or substantially similar in structure and function and are configured to operate correspondingly.
[0044] Fig. 5A depicts a perspective view of the hub 111, according to an embodiment of the present disclosure. The hub 111 is coupled to the distal end 103b of the shaft 103. In an embodiment, the hub 111 is tubular in shape, though any other shape of the hub 111 is within the scope of the teachings of the present disclosure. In an embodiment, the hub 111 defines a bore 111a extending longitudinally therethrough along a central axis of the hub 111. The bore 111a is configured to receive the distal end 103b of the shaft 103. The distal end 103b of the shaft 103 is fixedly secured within the bore 111a using one or more coupling techniques, including, but not limited to, press-fitting, adhesive bonding, welding, brazing, crimping, threaded engagement, or combinations thereof. In an embodiment, the hub 111 includes internal threads disposed on an inner surface of the bore 111a at a proximal end of the hub 111. The internal threads of the hub 111 are configured to mate with the corresponding external threads of the shaft 103.
[0045] Further, the hub 111 includes a plurality of coupling elements 111b disposed on an outer circumferential surface of the hub 111. The coupling element 111b is pivotally coupled to the corresponding connecting members 113 and allows angular movement of the connecting member 113 relative to the hub 111. In an embodiment, the coupling element 111b is radially disposed on an outer surface of the hub 111 and is configured to receive a corresponding connecting member 113. The coupling elements 111b may be uniformly spaced about the circumference of the hub 111 to ensure balanced force transmission and synchronized movement of the connecting members 113 during operation. However, alternative arrangements, including non-uniform spacing or asymmetric placement of the coupling elements 111b, may be employed without departing from the scope of the present disclosure. Accordingly, unless otherwise stated, any structural or functional description provided with respect to a single coupling element 111b shall be understood to apply equally to each of the plurality of coupling elements 111b disposed on the hub 111.
[0046] For the sake of clarity and ease of explanation, only one coupling element 111b of the plurality of coupling elements 111b disposed on the hub 111 is described in detail herein. It shall be understood that the remaining coupling elements 111b illustrated in Fig. 5A are identical or substantially similar in structure and function to the coupling element 111b described, and therefore operate correspondingly to pivotally couple the hub 111 with the respective connecting members 113. In an embodiment, the coupling element 111b includes a pair of walls 111b-1 disposed on the outer surface of the hub 111 and radially projecting outward from the outer surface of the hub 111. The walls 111b-1 are spaced apart from one another to define a gap therebetween. The gap is configured to receive the corresponding connecting member 113. Each coupling element 111b includes a transverse bar or pin 111b-2 disposed between the pair of walls 111b-1. The transverse bar is pivotally coupled to the connecting member 113, thereby enabling relative angular movement between the connecting member 113 and the hub 111. In an embodiment, the plurality of coupling elements 111b includes at least two coupling elements 111b as depicted in Fig. 5A. In alternative embodiments, the coupling elements may include three or more coupling elements 111b, without departing from the scope of the present disclosure.
[0047] For the sake of clarity and ease of explanation, only one connecting member 113 of the plurality of connecting members 113 is described in detail herein. It shall be understood that the remaining connecting member 113 illustrated in Fig. 5B is identical or substantially similar in structure and function to the connecting member 113 described, and therefore operates correspondingly to couple with the respective connecting members 113 pivotally and the gripping pad 113. Fig. 5B depicts a perspective view of the connecting member 113, according to an embodiment of the present disclosure. The connecting member 113 is pivotally coupled to the hub 111 and the gripping pad 113 and configured to transmit actuation forces from the actuation assembly 131 to the gripping pads 115. The connecting member 113 is a rectangular, elongated body. In an embodiment, the connecting member 113 includes a first connecting member 113a and a second connecting member 113b that are pivotally coupled to one another. The pivotal coupling between the first connecting member 113a and the second connecting member 113b allows relative angular movement therebetween, thereby enabling articulation of the connecting member 113 during operation of the device 100
[0048] In one embodiment, the connecting member 113 includes two connecting members, namely the first connecting member 113a and the second connecting member 113b, configured to transmit motion, force, or positional alignment between associated components of the device 100. In other embodiments, the connecting member 113 may include more than two connecting members, including a plurality of connecting members arranged in series, in parallel, or in a combination thereof, depending on structural and functional requirements.
[0049] In some embodiments, the connecting member 113 may include three or more connecting members sequentially coupled to one another to define a multi-segment connecting assembly. Such a configuration may facilitate improved flexibility, enhanced articulation, or controlled movement across multiple regions of the device. In certain embodiments, each connecting member may be identical in structure, while in other embodiments, one or more connecting members may differ in length, shape, cross-section, or material composition.
[0050] In an embodiment, the first connecting member 113a includes a first end 113a-1 pivotally coupled to a respective coupling element 111b of the hub 111 and a second end 113a-2. In an embodiment, the first end 133-1 of the first connecting member 113a is pivotally coupled to the transverse bar 111b-2 of the coupling element 111b of the hub 111. In an embodiment, the first connecting member 113a includes a first aperture 113a-3 disposed at the first end 113a-1 thereof and configured to receive the transverse bar 111b-2 of the coupling element 111b. Further, the first connecting member 113a includes a second aperture 113a-4 disposed at the second end 113a-2 thereof. The second aperture is configured to receive a coupling pin for pivotally coupling the first connecting member 113a to the second connecting member 113b.
[0051] The second connecting member 113b includes a first end 113b-1 and a second end 113b-2. The first end 113b-1 of the second connecting member 113b is pivotally coupled to the second end 113a-2 of the first connecting member 113a. In an embodiment, the second connecting member 113b includes a pair of walls 113b-3 disposed at the first end 113b-1 thereof and extending longitudinally. The walls 113b-3 are spaced apart from one another to define a gap configured to receive the second end 113a-2 of the first connecting member 113a. Each wall 113b-3 includes an aperture 113b-4 axially aligned with one another. The second aperture 113a-4 of the first connecting member 113a is aligned with the apertures 113b-4 of the walls 113b-3 of the second connecting member 113b to receive the coupling member 119, thereby establishing a pivotal connection between the first connecting member 113a and the second connecting member 113b. In an embodiment, the second connecting member 113b includes a hole 113b-5 disposed at the second end 113b-2 and configured to receive a coupling pin. The second end 113b-2 of the second connecting member 113b is pivotally coupled to the gripping pad 115. In an embodiment, the second end 113b-2 of the second connecting member 113b extends outwardly through the corresponding slot 109 of the sheath 105 (in other words, each slot 109 is configured to allow at least a portion of a corresponding second end 113b-2 of the second connecting member 113b to extend outwardly through the slot 109).
[0052] Fig. 5C depicts a perspective view of the gripping pad 115, according to an embodiment of the present disclosure. The gripping pad 115 is pivotally coupled to the connecting member 113. The pivotal coupling of the gripping pad 115 relative to the connecting members 113 and hub 111 enables controlled and synchronized movement of the gripping pads 115 between an inwardly retracted position defining a closed or engaged configuration and an outwardly extended position defining an open or release configuration. In the engaged configuration, the gripping pads 115 are moved radially inward to engage and securely retain the stent. In the release configuration, the gripping pads 115 are moved radially outward to disengage from the stent and permit deployment or release thereof.
[0053] In an embodiment, each gripping pad 115 is pivotally coupled to the second end 113b-2 of the corresponding second connecting member 113b. Each gripping pad 115 includes an engagement pad 115a configured to contact and interact with a target medical device, such as a stent. The engagement pad 115a may be contoured, textured, or shaped to enhance gripping efficiency and to minimize slippage during engagement. In one embodiment, the engagement pad 115a is configured to engage and secure the stent. In another embodiment, the engagement pad 115a is configured to apply a controlled force to the stent so as to press the stent against an adjacent catheter or delivery element. In one embodiment, the engagement pad 115a includes a concave inner surface facing toward a longitudinal axis of the device, the concave inner surface being configured to partially surround or cradle the stent when the gripping pad 115 is in the closed configuration. The curvature radius of the concave inner surface may be selected based on the diameter or geometry of the stent to be engaged.
[0054] The gripping pad 115 includes an engagement element 115b coupled to the engagement pad 115a and extending transversely therefrom. In an embodiment, the engagement element 115b extends transversely from the engagement pad 115a and is structured to facilitate mechanical coupling of the gripping pad 115 to the corresponding second connecting member 113b. The engagement element 115b may be configured in the form of a projection, lug, tab, or stem adapted to be received within a complementary opening, recess, or fastening interface provided on the second connecting member 113b, thereby enabling secure attachment and transmission of actuation forces. In an embodiment, the engagement pad 115a and the engagement element 115b are integrally formed as a single, unitary component. Such monolithic construction enhances structural strength, ensures precise alignment between the gripping interface and the connecting structure, and reduces the likelihood of loosening or mechanical failure during repeated gripping and release cycles. The engagement element 115b is configured to couple the gripping pad 115 to the corresponding second connecting member 113b.
[0055] In an embodiment, the engagement element 115b includes a pair of walls 115b-1 extending longitudinally therefrom. The walls 115b-1 are spaced apart from one another to define a gap configured to receive the second end 113b-2 of the second connecting member 113b. Each wall 115b-1 of the engagement element 115b includes an aperture 115b-2, wherein the apertures 115b-2 are axially aligned with one another. The hole 113b-5 of the second connecting member 113b is aligned with the apertures 115b-2 of the walls 115b-1 to receive a coupling pin, thereby establishing a pivotal connection between the second connecting member 113b and the gripping pad 115. In an embodiment, the pivotal coupling between the gripping pad 115 and the second connecting member 113b enables self-alignment of the engagement pad 115a with respect to the stent or target structure, thereby improving gripping reliability and reducing localized stress on the stent. In an embodiment, the gripping pad 115 may be formed from a biocompatible material, including but not limited to polymers, elastomers, metals, or combinations thereof. The engagement pad 115a may optionally include a compliant or high-friction surface coating to enhance gripping performance while minimizing trauma to the stent or surrounding structures.
[0056] The resilient member 121 is disposed at a respective connecting member 113. In particular, the resilient member 121 is disposed proximate to a junction between the first connecting member 113a and the second connecting member 113b. The resilient member 121 is operatively coupled to the first connecting member 113a and the second connecting member 113b and is configured to exert a biasing force to retain the gripping pad 115 in the open configuration in the absence of an externally applied actuating force. In this manner, the resilient member 121 maintains the gripping pad 115 in a normally open configuration and enables controlled closure only upon application of the actuating force. The resilient member 121 limits excessive distal movement and angular displacement of the first connecting member 113a and the second connecting member 113b during actuation, thereby preventing overextension and reducing mechanical stress at the junction. Upon release of the actuating force, the resilient member 121 facilitates automatic restoration of the connecting member 113 to an original, neutral, or default orientation, ensuring repeatable and reliable operation of the gripping mechanism.
[0057] In various embodiments, the resilient member 121 may be configured as a spring element, elastic element, or super elastic element, and may be formed from one or more biocompatible materials, including, but not limited to, stainless steel, cobalt-chromium alloys, polymeric elastomers, shape memory alloys, or any one or combination thereof. In one embodiment, the resilient member 121 is formed from nitinol, thereby providing superelastic properties that accommodate repeated deformation while maintaining a consistent biasing force over multiple actuation cycles.
[0058] Fig. 5D depicts a perspective view of the coupling member 119, according to an embodiment of the present disclosure. The coupling member 119 is disposed at the junction between the first connecting member 113a and the second connecting member 113b, and pivotally couples the first connecting member 113a with the second connecting member 113b. Further, the coupling member 119 pivotally couples the connecting member 113 and the actuation assembly 131. In an embodiment, the coupling member 119 includes a first end 119a having a generally U-shaped or looped configuration defining an internal passage or clearance region. The first end 119a includes a first limb and a second limb connected by a second end 119b of the coupling member 119, thereby forming a rigid yet compact coupling structure of the coupling member 119.
[0059] The coupling member 119 includes an eyelet 119c disposed at the first end 119a and configured to couple with the actuation assembly 131. The second end 119b is rotatably coupled to the junction between the first connecting member 113a and the second connecting member 113b of the corresponding connecting member 113. In one embodiment, the second end 119b is disposed within aligned apertures (113a-4, 113b-4) of the first connecting member 113a and the second connecting member 113b, thereby defining a pivot axis about which the first connecting member 113a and the second connecting member 113b are angularly movable relative to one another. The coupling member 119 functions as a pivoting linkage that permits angular movement while maintaining tensile load transfer between the actuation assembly 131 and the connecting member 113. The coupling member 119 may be implemented as, but is not limited to, a hinge element, clevis pin assembly, loop connector, articulated link, or pivot pin structure. In one embodiment, the coupling member 119 is configured as a hinge element.
[0060] Fig. 6 depicts a perspective view of the actuating assembly 131, according to an embodiment of the present disclosure. The actuation assembly 131 is operatively coupled to the gripper assembly 110 and configured to selectively actuate the gripper assembly 110 between an open configuration and a closed configuration. In the open configuration, the gripper assembly 110 releases the stent, whereas in the closed configuration, the gripper assembly 110 secures the stent. The actuation assembly 131 is disposed within the sheath 105 and the handle 130. In an embodiment, the actuation assembly 131 is at least partially disposed within the sheath 105 and the handle 130. The actuation assembly 131 is coupled to the connecting members 113. In an embodiment, the actuation assembly 131 is operatively coupled to the coupling members 119 of the gripper assembly 110. The actuation assembly 131 is configured to actuate the connecting member 113 to toggle the gripping pad 115 between the open configuration and the closed configuration.
[0061] In an embodiment, the actuation assembly 131 includes an actuator 133 and a plurality of anchor wires 135 extending longitudinally along the shaft 103 of the device 100. Each anchor wire 135 is configured to transmit an actuation force from the actuator 133 to the corresponding coupling member 119 of the gripper assembly 110. For ease of explanation and clarity, only one anchor wire 135 is described in detail herein. It shall be understood that the remaining anchor wires 135 illustrated in Fig. 6 are identical or substantially similar in structure and function and operate correspondingly. Each anchor wire 135 includes a proximal end 135a operatively coupled to the actuator 133, and a distal end 135b is coupled to a corresponding connecting member 113 via the coupling member 119. In an embodiment, the distal end 135b is coupled to the eyelet 119c disposed at the first end 119a of the coupling member 119 (in other words, the first end 119a of the coupling member 119 is coupled to the distal end 135b of the corresponding anchor wire 135).
[0062] Fig. 6A depicts a perspective view of the actuator 133, according to an embodiment of the present disclosure. The actuator 133 is slidably disposed at the proximal end 103a of the shaft 103. The actuator 133 protrudes through the longitudinal slot 134 of the handle 130. The actuator 133 is configured to translate axially along the longitudinal slot 134 of the shaft 103 between the first position and the second position. In an embodiment, the longitudinal slot 134 is configured to receive a portion of the actuator 133 and allow longitudinal movement of the actuator 133 between a first position and a second position, thereby enabling selective actuation of the gripping pads 115 of the gripper assembly 110. In an embodiment, the actuator 133 includes a first end 133a and a second end 133b. The first end 133a defines an aperture 145 configured to receive the shaft 103 therethrough, such that the actuator 133 is guided for linear movement along the longitudinal axis of the shaft 103. The first end 133a is operatively coupled to the proximal end 135a of the anchor wire 135, such that axial movement of the actuator 133 imparts a corresponding tensile force to the anchor wire 135. The actuator 133 includes a knob 143 disposed at the second end 133b thereof. The knob 143 projects through the longitudinal slot 134 of the handle 130 and is configured to be manually manipulated by a user. Movement of the actuator 133 between the first position and the second position causes corresponding axial displacement of the actuator 133 along the shaft 103, thereby selectively actuating the gripping pads 115 between the open configuration and the closed configuration.
[0063] Fig. 7 depicts a perspective view of the lock ring 139, according to an embodiment of the present disclosure. The lock ring 139 is disposed within the circumferential groove 136 of the handle 130. In particular, the lock ring 139 is disposed within the circumferential groove 136 of the handle 130 and configured to rotate about a central axis of the handle 130. The lock ring 139 is configured to selectively retain the actuator 133 in a locked position. In an embodiment, the lock ring 139 has a knurling texture on the outer surface. This helps in the easy grip for the health practitioner for rotating the lock ring 139. In an embodiment, the inner diameter of the lock ring 139 is equal to the outer diameter of the circumferential groove 136 of the handle 130. In an embodiment, the lock ring 139 includes a slot 140 configured to permit movement of the actuator 133 when the slot 140 of the lock ring 139 is aligned with the longitudinal slot 134 of the handle 130. The width of the slot 140 may be equal to or greater than the width of the longitudinal slot 134 of the handle 130. In an embodiment, the width of the opening is equal to the longitudinal slot 134 of the handle 130.
[0064] In accordance with the working of the device 100, according to an embodiment of the present disclosure, the gripper assembly 110 is normally maintained in the open configuration under the biasing force applied by the resilient members 121. In this open configuration, the gripping pads 115 are radially displaced away from the central longitudinal axis of the device 100, thereby permitting unhindered positioning of the stent adjacent to the distal end 105b of the sheath 105. In this state, the actuator 133 is positioned at the first position. The slot 140 of the lock ring 139 is aligned with the longitudinal slot 134 of the handle 130 to permit free axial movement of the actuator 133.
[0065] Upon manipulation of the device 100, the actuator 133 is moved from the first position toward the second position along the longitudinal slot 134. Such displacement of the actuator 133 imparts the tensile force to the anchor wire 135 operatively coupled thereto. The tensile force is converted into angular movement by articulation of the gripping assembly 110. In an embodiment, the coupling member 119 transmits a tensile force from the corresponding anchor wire 135 to the connecting member 113. In an embodiment, the first connecting member 113a pivots relative to the hub 111 about the transverse bar 111b-2, while the second connecting member 113b pivots relative to the gripping pad 115 about the engagement element 115b. This coordinated articulation of the connecting members 113 transforms axial tensile force into controlled radial displacement of the gripping pads 115 toward the central longitudinal axis of the device 100. Consequently, the gripping pads 115 transition from the open configuration to the closed configuration, wherein the engagement pads 115a move inwardly to contact and securely engage a stent 802, as depicted in Fig. 8A. During inward movement of the gripping pads 115, the resilient members 121 exert a counter-biasing force that limits excessive angular displacement of the connecting members 113, prevents mechanical over-travel of the gripping pads 115, and ensures stable gripping without structural overstress. Once the actuator 133 reaches the second position, the lock ring 139 is rotated about the longitudinal axis of the handle 130 such that the slot 140 of the lock ring 139 is misaligned with the longitudinal slot 134 of the handle 130 as depicted in Fig. 8A. This configuration restrains further axial movement of the actuator 133, thereby retaining the gripping pads 115 in the closed configuration and securely maintaining the stent relative to the sheath 105 during delivery, repositioning, or deployment.
[0066] To release the stent, the lock ring 139 is rotated to realign the slot 140 with the longitudinal slot 134 of the handle 130, thereby permitting axial movement of the actuator 133 from the second position to the first position, as depicted in Fig. 8B. Upon such movement, tensile force in the anchor wires 135 is reduced or eliminated, allowing the resilient members 121 to restore the connecting members 113 to their default orientations. This results in outward radial displacement of the gripping pads 115 away from the stent 802, thereby transitioning the gripper assembly 110 back to the open configuration and releasing the stent 802.
[0067] Fig. 9 depicts a flowchart of a method 900 for deploying a stent 802 within a body lumen 806 using the delivery device 100, according to an embodiment of the present disclosure. The method 900 describes a controlled sequence for positioning and releasing the stent 802 at a target site within the body lumen 806.
[0068] At step 902, load the stent 802 onto the delivery device 100. In particular, the stent 802 is positioned over the sheath 105 and disposed within a catheter 804 such that the stent 802 is maintained in a radially constrained configuration. The gripping pad 115 secures the stent 802 in place and prevents unintended axial displacement during handling and insertion. The stent 802 is thereby retained in a compressed state suitable for transluminal delivery, as described earlier with reference to the structural configuration of the delivery device 100.
[0069] In an alternative embodiment, when the stent 802 is disposed within the catheter 804, the gripping pad 115 applies a radially directed force to the stent 802. The radially directed force is generated by the resilient member 121, which biases the gripping pad 115 toward the stent 802 such that the stent 802 is urged against an inner surface of the catheter 804, as depicted in Fig. 8C. This radial biasing securely retains the stent 802 within the catheter 804 and prevents unintended displacement of the stent 802, as depicted in Fig. 8Cduring handling and navigation of the delivery device 100 toward the target site.
[0070] At step 904, introduce the delivery device 100 into the body lumen 806 of a patient and advance towards the target site. The distal end 100b of the delivery device 100 is navigated through the vasculature or other anatomical passageway using conventional interventional techniques. During advancement, the catheter 804 circumferentially surrounds and constrains the stent 802 to prevent premature expansion. Additionally, the retainer ring 107 provides structural reinforcement and inhibits unintended axial or radial movement of the stent 802 relative to the delivery device 100. This arrangement ensures stable tracking, accurate positioning, and controlled handling of the stent 802 while navigating tortuous anatomical pathways.
[0071] At step 906, deploy the stent 802 at the target site by advancing the distal end 100b of the device 100 relative to the catheter 804 such that the distal end of the stent 802 begins to emerge from the catheter 804. Thereafter, the actuator 133 is released by rotating the lock ring 139 to align the slot 140 of the lock ring 139 with the longitudinal slot 134. This alignment permits the actuator 133 to move from the second (locked) position to the first (release) position. Movement of the actuator 133 disengages the gripping pad 115 from the stent 802, thereby removing the axial constraint. As the catheter 804 is progressively retracted or as the stent 802 is advanced distally relative to the catheter 804, the stent 802 is gradually exposed. Upon exposure, and in the absence of external constraining forces, the stent 802 self-expands radially to engage an inner wall of the body lumen 806. The controlled and incremental release allows precise placement and proper apposition of the stent 802 against the vessel wall at the target site.
[0072] In an alternate embodiment, the radial retaining force applied to the stent 802 is removed by actuating the actuator 133 from the first position to the second position, as described above. Upon removal of the radial constraint, the stent 802 is deployed at the target site by retracting the catheter 804 proximally relative to the device 100, such that the distal portion of the stent 802 begins to emerge from the distal end of the catheter 804, as depicted in Fig. 8D. As the catheter 804 is progressively retracted, the stent 802 is gradually exposed and allowed to expand radially to engage an inner wall of the body lumen 806, as depicted in Fig. 8D.
[0073] At step 810, withdraw the delivery device 100 from the patient's body. The catheter 804 and associated components are carefully retracted while maintaining the stent 802 in its deployed position. The method 900 is thereby completed, leaving the stent 802 securely expanded within the body lumen 806 to perform the intended therapeutic function.
[0074] The present delivery device offers multiple advantages over conventional stent deployment systems. The device is configured to securely retain the stent during advancement through a catheter or body lumen, thereby substantially preventing premature deployment and unintended release. The gripping assembly maintains positional stability of the stent relative to the sheath, which minimizes axial or radial displacement during insertion and navigation through tortuous anatomy. Furthermore, the actuation assembly enables controlled and selective detachment of the stent, ensuring that release occurs only after the stent has been accurately positioned at a desired target site. This controlled deployment improves placement precision, enhances procedural safety, and reduces the risk of mispositioning, vessel injury, or the need for corrective interventions.
[0075] 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 intended to be exemplary, and that the actual selections will depend upon the specific application or applications for which the teachings of the present invention are used.
, Claims:WE CLAIM
1. A delivery device (100) for deploying a stent within a body lumen, the delivery device (100) comprising:
a. a shaft (103) extending between a proximal end (103a) and a distal end (103b) of the shaft (103);
b. a gripper assembly (110) disposed at the distal end (103b) of the shaft (103), the gripper assembly (110) comprises:
i. a hub (111) coupled to the distal end (103b) of the shaft (103) and having a plurality of coupling elements (111b);
ii. a plurality of connecting members (113) pivotally coupled to the hub (111), each connecting member (113) comprises:
a. a first connecting member (113a) having a first end (113a-1) pivotally coupled to a respective coupling element (111b) of the hub (111) and a second end (113a-2);
b. a second connecting member (113b) having a first end (113b-1) pivotally coupled to the second end (113a-2) of the first connecting member (113a) and a second end (113b-2); and
iii. a plurality of gripping pads (115), each gripping pad (115) pivotally coupled to the second end (113b-2) of a corresponding second connecting member (113b) and configured to engage with the stent; and
c. an actuation assembly (131) coupled to the connecting members (113), and configured to actuate the connecting members (113) to toggle the gripping pads (115) between an open configuration and a closed configuration.
2. The delivery device (100) as claimed in claim 1, wherein the actuation assembly (131) comprises:
a. an actuator (133) slidably disposed at the proximal end (103a) of the shaft (103); and
b. a plurality of anchor wires (135) extending longitudinally along the shaft (103), each anchor wire (135) having a proximal end (135a) coupled to the actuator (133) and a distal end (135b) coupled to a corresponding connecting member (113) via a coupling member (119).
3. The delivery device (100) as claimed in claim 2, wherein the coupling member (119) comprises:
a. a first end (119a) coupled to a distal end (135b) of the corresponding anchor wire (135); and
b. a second end (119b) coupled to a junction between the first connecting member (113a) and the second coupling member (113b) of the corresponding connecting member (113); and
c. wherein the coupling member (119) is configured to transmit a tensile force from the corresponding anchor wire (135) to the connecting member (113).
4. The delivery device (100) as claimed in claim 1, wherein the delivery device (100) comprises a sheath (105) including:
a. a lumen (106) extending longitudinally between a proximal end (105a) and a distal end (105b) of the sheath (105); and
b. a plurality of slots (109) formed through a wall of the sheath (105) at the distal end thereof, each slot (109) being configured to allow at least a portion of a corresponding second end (113b-2) of the second connecting member (113b) to extend outwardly through the slot (109).
5. The delivery device (100) as claimed in claim 4, wherein the delivery device (100) comprises a retainer ring (107) disposed on an outer surface of the sheath (105) at the distal end (105b) thereof, and configured to retain the stent relative to the sheath (105).
6. The delivery device (100) as claimed in claim 4, wherein the delivery device (100) comprises a handle (130) coupled to the proximal end (105a) of the sheath (105), the handle (130) comprises:
a. a longitudinal slot (134) disposed on a wall of the handle (130) and configured to receive a portion of the actuator (133) and allow longitudinal movement of the actuator (133) between a first position and a second position; and
b. a circumferential groove (136) disposed on an outer surface of the handle (130) at a proximal end of the longitudinal slot (134), and configured to receive a lock ring (139) of the delivery device (100) and allow rotation about a longitudinal axis of the handle (130).
7. The delivery device (100) as claimed in claim 6, wherein the lock ring (139) is disposed within the circumferential groove (136) of the handle (130), the lock ring (139) being configured to retain the actuator (133) in a locked position.
8. The delivery device (100) as claimed in claim 7, wherein the lock ring (139) comprises a slot (140) configured to permit movement of the actuator (133) along the slot (140) when the lock ring (139) is aligned with the longitudinal slot (134) of the handle (130).
9. The delivery device (100) as claimed in claim 1, wherein the delivery device (100) comprises a resilient member (121) disposed at a respective connecting member (113), the resilient member (121) configured to exert a biasing force to retain the gripping pad (115) in the open configuration.
10. The delivery device (100) as claimed in claim 9, wherein the resilient member (121) is formed from one or more biocompatible materials, including stainless steel, cobalt-chromium alloys, polymeric elastomers, shape memory alloys, or any one or combination thereof.