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:
EMBOLIZATION IMPLANT AND A DEPLOYMENT DEVICE THEREOF

2. APPLICANTS:
Meril Corporation (I) Private Limited, an Indian Company of the address, Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India

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

 
FIELD OF INVENTION
[001] The present invention relates to a medical device. More specifically, the present invention relates to for an embolization implant and a deployment device thereof.
BACKGROUND OF INVENTION
[002] An embolization coil (or an implant) is used in an interventional procedure to block blood flow in a medium to large-sized blood vessel or aneurysm. The coil is placed inside a vessel, effectively preventing blood from flowing through it. The coil may be made of, for example, a flexible metallic wire and may be configured as a helically wound coil, a randomly wound coil, or a coil wound within a coil, depending on the clinical application.
[003] The implant is deployed in a target site within the vasculature using a catheter-based deployment device (deployment device). Once the deployment device is navigated to the target site, the coil is released to fill the target area, thereby creating a blockage. The deployment device is especially useful for navigating a complex vascular structure, such as a tortuous blood vessel in the human brain, ensuring high precision when deploying the coil to a specific site within a vessel or an aneurysm.
[004] However, a conventional deployment device can sometimes result in an accidental deployment of the coil, a phenomenon known as non-target embolization. The accidental coil deployment occurs when the coil is unintentionally released or the coil migrates from the intended target site during the procedure. Such an event may occur due to factors including tortuosity of the vessel, unintentional push or pull forces during navigation, improper selection of the deployment device, operator error, etc. In the conventional deployment device, the detachment mechanism lacks a controlled deployment mechanism for easy detachment and operator control. This can lead to premature coil deployment. The absence of an effective deployment device can lead to non-target embolization, even when operated by a skilled professional. The consequence of non-target embolization can be severe, potentially leading to the occlusion of a non-target vessel and a harmful clinical outcome.
[005] Hence, there is a need for a deployment device which can overcome the above limitations.
SUMMARY OF INVENTION
[006] The present invention relates to an implant. The implant includes a coil that extends from a proximal end to a distal end. The implant further includes an inner jacket. The inner jacket is coupled to a proximal end of the coil. The inner jacket is configured to operatively couple to a deployment device. The inner jacket includes a plurality of slots provided at a distal portion of the inner jacket and a plurality of flaps provided at the distal portion. A flap of the plurality of flaps alternates with a slot of the plurality of slots. The flaps are configured to radially expand to decouple the implant from the deployment device for deployment at a target site.
[007] In accordance with an alternative embodiment of the present invention, an implant is disclosed. The implant includes a coil, an outer jacket and an inner jacket. The coil that extends from a proximal end to a distal end. The outer jacket is coupled to a proximal end of the coil. The inner jacket is coupled to a proximal end of the outer jacket. The inner jacket is configured to operatively couple to a deployment device. The inner jacket includes a plurality of slots and a plurality of flaps. The plurality of slots provided at a distal portion of the inner jacket. The plurality of flaps provided at the distal portion, with a flap of the plurality of flaps alternating with a slot of the plurality of slots. The flaps are configured to radially expand to decouple the implant from the deployment device for deployment at a target site.
[008] In accordance with an embodiment of the present invention, a deployment device for deploying an implant is disclosed. The deployment device includes an outer shaft, an inner shaft and a locking member. The outer shaft includes an outer shaft lumen, a proximal end and a distal end. The distal end is in proximity to an implant. The inner shaft is operatively coupled to the outer shaft lumen. The inner shaft includes an anchor at its distal end to hold the implant and one or more stoppers at its proximal end. The locking member is removably coupled to the proximal end of the outer shaft. The locking member includes a lumen having a proximal portion. A proximal portion of the inner shaft is movably disposed in the proximal portion of the lumen. The one or more stoppers of the inner shaft temporarily lock with a distal end of the proximal portion upon proximal movement of the locking member, resulting in deployment of the implant.
[009] In accordance with another embodiment of the present invention, a method for decoupling an implant from a deployment device is disclosed. The method involves a deployment device that includes an anchor of an inner shaft, which is at least partially disposed within the implant, and a locking member that is attached to the distal end of an outer shaft. The process begins with the disengagement of the locking member from the outer shaft. Next, the locking member is pulled proximally by a predetermined distance relative to the outer shaft. This causes one or more stoppers on the inner shaft to temporarily engage with the distal end of the proximal portion of the locking member. When the locking member is pulled proximally beyond the predefined distance relative to the outer shaft, it triggers the retraction of the inner shaft, effectively decoupling the implant from the inner shaft for deployment at the target site.
[0010] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[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 cross-sectional view of a deployment device 200 with an implant 100, according to an embodiment of the present disclosure.
[0013] Fig. 1B depicts an exploded view of the deployment device 200 with the implant 100, according to an embodiment of the present disclosure.
[0014] Fig. 2A depicts a perspective view of the implant 100, according to an embodiment of the present disclosure.
[0015] Fig. 2B depicts a perspective view of the implant 100, according to an alternative embodiment of the present disclosure.
[0016] Fig. 2C depicts a perspective view of the implant 100 coupled to an inner jacket 140, according to an alternative embodiment of the present disclosure.
[0017] Figs. 3A – 3B depicts perspective views of an outer jacket 130 of the implant 100, according to an embodiment of the present disclosure.
[0018] Fig. 4 depicts a perspective view of an inner jacket 140 of the implant 100, according to an embodiment of the present disclosure.
[0019] Fig. 5 depicts a perspective view of an outer shaft 300 of the deployment device 200, according to an embodiment of the present disclosure.
[0020] Fig. 6 depicts a perspective view of an inner shaft 400 of the deployment device 200, according to an embodiment of the present disclosure.
[0021] Figs. 7A–7C depict various views of a locking member 500 of the deployment device 200, according to an embodiment of the present disclosure.
[0022] Fig. 8A depict cross-sectional views of the deployment device 200 at an undeployed state, according to an embodiment of the present disclosure.
[0023] Fig. 8B depict cross-sectional views of the deployment device 200 at a deployed state, according to an embodiment of the present disclosure.
[0024] Fig. 9 depicts a flowchart of a method 900 for deploying the implant 100 using the deployment device 200, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0025] 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.
[0026] 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.
[0027] 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.
[0028] 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.
[0029] In accordance with the present disclosure, a deployment device to deploy an implant is disclosed. The deployment device is used to carry and deploy the implant at a target site. In an embodiment, the implant is coupled to the deployment device using mechanical coupling. In an embodiment, the deployment device includes an inner jacket, an outer jacket, a locking member, and an inner shaft. At least the inner jacket is used to couple the implant to a distal end of the deployment device. Additionally, and optionally, the outer jacket may be coupled to the implant. The deployment device with the implant is placed at the target site using a catheter. For detachment of the implant from the deployment device at the target site, the locking member is pulled in a proximal (upwards) direction along with the inner shaft.
[0030] The deployment device of the present invention provides several advantages over a conventional deployment device. The inner jacket and optionally, the outer jacket of the deployment device facilitate mechanical coupling of the implant with the deployment device, avoiding unpredictable detachment. Unlike other detachment methods, the mechanical coupling provides instant detachment without delay, which is crucial in a time-sensitive or high-risk procedure. Further, the locking member is configured to control the movement of the inner shaft, resulting in controlled detachment of the implant from the deployment device and/or minimizing the risk of accidental deployment, misplacement, or unintended implant migration. With precise and controlled implant deployment, the deployment device improves treatment outcomes and patient safety for vascular conditions, including aneurysm, arteriovenous malformation, etc. The deployment device offers a minimally invasive alternative to open surgery, thereby reducing recovery time and minimizing the risks associated with a traditional procedure.
[0031] Now referring to figures, Fig. 1A depicts a cross-sectional view and Fig. 1B depicts an exploded view of an implant 100 and a deployment device 200, according to an embodiment of the present disclosure. The deployment device 200 is used to deploy the implant 100 at a target site. The target site may, without limitation, include a blood vessel, an aneurysm, an arteriovenous malformation, etc., in a patient.
[0032] The deployment device 200 includes the proximal end 200a and the distal end 200b. It is to be noted that a proximal end 200a and a distal end 200b are used as references to describe the respective ends of the plurality of components of a deployment device 200. Each component of the deployment device 200 has respective ends, the end towards the proximal end 200a is referred to as a proximal end of that component, similarly, the end towards the distal end 200b is referred to as a distal end of that component. According to an embodiment, the deployment device 200 includes an outer shaft 300, an inner shaft 400, and a locking member 500. Additionally, the deployment device 200 is coupled to the implant 100 at the distal end 200b of the deployment device 200.
[0033] Fig. 2A depicts a perspective view and Fig. 2B depicts a cross-sectional view of the implant 100, according to an embodiment of the present disclosure. The implant 100 includes a proximal end 100a and a distal end 100b. In an embodiment, the implant 100 includes a coil 120, an optional outer jacket 130 and an inner jacket 140. In an embodiment, the coil 120 includes a plurality of coils housed one inside the other, extending at least partially along its length. Alternately, the coil 120 of the implant 100 may be formed by coiling a single wire or a plurality of wires for only a predefined length of the coil 120. The coil 120 extends between the proximal end 100a and the distal end 100b of the implant 100. The coil 120 may be made of a suitable biocompatible material, such as, without limitation, platinum, platinum-tungsten, platinum-iridium, tungsten, stainless steel, nitinol, nickel-titanium, etc. In an embodiment, the coil 120 is made of platinum-tungsten.
[0034] In an embodiment, the proximal end 100a of the implant 100 includes the outer jacket 130. The coupling of the two is described in Fig. 3B. In another embodiment, the proximal end 100a of the implant 100 may be include inner jacket 140, as shown in Fig. 2C. In this embodiment, the coil 120 is coupled to the inner jacket 140. The distal end 100b of the implant 100 includes a cap 100c (shown in Fig. 2A and 2B) and configured to facilitate smooth navigation of the implant 100. The cap 100c is coupled to the distal end of the coil 120 using a coupling technique including, but not limited to, crimping, press-fit, threading, medical-grade epoxy, silicone adhesive, UV-curable adhesive, heat shrinking, thermal fusion, plasma treatment, silane coupling, etc. In an embodiment, the cap 100c is coupled to the distal end of the coil 120 using UV-curable adhesive. In another embodiment, the distal end of the coil 120 is received within a cavity formed in the cap 100c and secured using medical-grade adhesive.
[0035] The cap 100c includes a rounded, dome-shaped structure designed to cover the terminal end of the coil 120, thereby facilitating smooth navigation of the implant 100 while minimizing trauma to surrounding tissues. The cap 100c may define a predefined outer diameter and inner cavity dimension configured to accommodate the distal windings of the coil 120. In an embodiment, the cap 100c is made of a biocompatible material, including, without limitation, silicone rubber, thermoplastic elastomer, hydrogel, n-butyl cyanoacrylate (NBCA), nylon, polyethylene terephthalate, polyester, silk, PVA, soft polymer, etc. In an embodiment, the cap 100c is made of soft polymer.
[0036] Further, the implant 100 may be self-expanding and/or may acquire a secondary shape to fill the aneurysmal sac at a treatment site. The secondary shape is a shape attained by the coil 120 after deployment at the target site. The secondary shape may include without limitation, a helical shape, a twister shape, a diamond shape etc. The aforesaid shapes of the coil 120 may fill a lumen of the vasculature upon deployment.
[0037] Additionally, and/or optionally, the outer jacket 130 is disposed towards the proximal end 100a of the implant 100. Figs. 3A and 3B depict various perspective views of the outer jacket 130 of the implant 100, according to an embodiment of the present disclosure. The outer jacket 130 includes a proximal end at the proximal end 100a of the implant 100 and a distal end at the distal end 100b of the implant 100. The outer jacket 130 may include an inner lumen 132 that is configured to house at least a portion of the inner jacket 140.
[0038] The distal end of the outer jacket 130 is coupled to the proximal end of the coil 120 (Fig. 3b). The outer jacket 130 is coupled to the coil 120 using a coupling technique including, but not limited to, snap-fit, welding, micro-adhesive bonding, heat shrinking, plasma surface treatment and adhesive, etc. In an embodiment, the distal end of the outer jacket 130 is coupled to the proximal end of the coil 120 via welding. In another embodiment, the proximal end of the coil 120 is coupled to an inner surface of the outer jacket 130.
[0039] The outer jacket 130 includes a tubular structure defining a predefined outer diameter and a predefined inner diameter ranging from 0.20 mm to 0.35 mm and 0.10 mm to 0.30 mm, respectively. In an embodiment, the outer diameter and the inner diameter of the outer jacket 130 is 0.30 mm and 0.20 mm, respectively. In an embodiment, the outer jacket 130 may be made of a biocompatible material without limitation, including, platinum, stainless steel, inconel (nickel-based superalloy), nitinol (nickel-titanium alloy), etc. In an embodiment, the outer jacket 130 is made of platinum.
[0040] Fig. 4 depicts a perspective view of the inner jacket 140 of the implant 100, according to an embodiment of the present disclosure. In an embodiment, the inner jacket 140 includes a proximal end 140a, a distal end 140b, a proximal portion 140c and a distal portion 140d. The inner jacket 140 is coupled to the proximal end 100a of the implant 100. In other words, the inner jacket 140 coupled to the proximal end of the coil 120 and configured to operatively couple to a deployment device 200. The proximal portion 140c of the inner jacket 140 is coupled to at least a proximal portion of the outer jacket 130. The proximal portion 140c of the inner jacket 140 is coupled to the proximal portion of the outer jacket 130 using a coupling technique including, but not limited to, snap-fit, welding, micro-adhesive bonding, threaded lock, etc. In an embodiment, the proximal portion 140c is coupled to the outer jacket 130 using welding.
[0041] The proximal portion 140c and the distal portion 140d of the inner jacket 140 are hollow, defining an inner jacket lumen 142. The inner jacket lumen 142 is configured to house a portion of a distal end of the inner shaft 400. The inner jacket 140 is disposed on the distal portion of the inner shaft 400 of the deployment device 200. The inner jacket 140 is coupled to the inner shaft 400 using a coupling technique including, but not limited to, snap-fit, mechanical coupling, bayonet lock, friction fit, magnetic lock, threaded lock, expandable sleeve lock, etc. In an embodiment, inner jacket 140 is coupled to the inner shaft 400 using mechanical coupling (explained later).
[0042] The proximal portion 140c may have a pre-defined shape such as cylindrical, cuboidal, tapered, conical, etc. In an embodiment, the proximal portion 140c includes a cylindrical shape. The length of the proximal portion 140c may range from 0.30 mm to 0.80 mm. In an embodiment, the length of the proximal portion 140c is 0.50 mm. The diameter of the proximal portion 140c may range between 0.10 mm and 0.30 mm. In an exemplary implementation, the diameter of the proximal portion 140c is 0.22 mm. In an embodiment, the diameter of the proximal portion 140c is more than the diameter of the distal end of the inner shaft 400. The proximal portion 140c of the inner jacket 140 may be made of a biocompatible material, including, without limitation, platinum, stainless steel, inconel (nickel-based superalloy), nitinol (nickel-titanium alloy), etc. In an exemplary implementation, the proximal portion 140c is made of platinum. In an embodiment, the coil 120 is coupled to an outer surface of the proximal portion 140c of the inner jacket 140 as shown in Fig. 2C.
[0043] The distal portion 140d of the inner jacket 140 is configured to be operatively coupled to the distal portion in the inner shaft 400 of the deployment device 200. The operatively coupling refers to engagement between the implant 100 and the deployment device 200 while the inner shaft 400 is moved axially in the inner jacket 140 to deploy the implant 100. The distal portion 140d may have various shapes, including but not limited to, cylindrical, conical, frustum, etc. In an exemplary implementation, the distal portion 140d includes a conical shape with a taper towards the distal end 140b of the inner jacket 140.
[0044] The length of the distal portion 140d may range from 0.50 mm to 2 mm. In an embodiment, the length of the distal portion 140d is 1 mm. The diameter of the distal portion 140d may depend on the diameter of the inner shaft 400. In an embodiment, the diameter of a distal end of the distal portion 140d is equal to or less than the diameter of the inner shaft 400. The diameter of the distal portion 140d may range between 0.15 mm and 0.30 mm. In an exemplary implementation, the diameter of the distal portion 140d is 0.22 mm. The distal portion 140d of the inner jacket 140 may be made of a flexible biocompatible material, including, without limitation, platinum, stainless steel, inconel (nickel-based superalloy), nitinol (nickel-titanium alloy), etc. In an exemplary implementation, the distal portion 140d is made of platinum.
[0045] In an embodiment, the distal portion 140d of the inner jacket 140 includes a plurality of slots 144 and flaps 146. The flaps 146 and the slots 144 are provided circumferentially, such that the flaps 146 and the slots alternate with each other. The plurality of slot 144 is provided at a distal portion 140d of the inner jacket 140. The slots 144 extend at least partially from the distal end 140b towards the proximal end 140a of the inner jacket 140. The slots 144 facilitate expansion of the inner jacket 140, thereby enabling easy decoupling of the inner jacket 140 from the inner shaft 400. This makes the deployment of the implant 100 at a target site more efficient and faster.
[0046] The slots 144 may be distributed uniformly or non-uniformly depending upon the spacing between two consecutive flaps. The shape of the slots 144 may be tapered, rectangular, circular, oval, keyhole, T-shaped, etc. In an embodiment, the shape of the slots 144 is rectangular. The number of slots 144 may be in the range from 2 to 4. In an exemplary embodiment, the number of slots 144 in the inner jacket 140 is three. The length of the slots 144 may range between 0.10 mm and 1.5 mm. In an embodiment, the length of the slots 144 is 0.8 mm.
[0047] The plurality of flaps 146 is provided at the distal portion 140d, and the flaps 146 of the plurality of flaps 146 alternate with the slot 144 of the plurality of slots 144. In an embodiment, the flaps 146 are flexible strips disposed in the distal portion 140d of the inner jacket 140. The flaps 146 are configured to radially expand to decouple the implant 100 from the deployment device 200 for deployment at a target site. In other words, the flaps 146 are configured to expand radially outwards upon proximal pulling of the inner shaft 400, enabling decoupling of the inner jacket 140. Specifically, when the inner shaft 400 is pulled proximally, the flaps 146 experience an outward force. Due to this, the flaps 146 expand into the slots 144 in the distal portion 140d of the inner jacket 140. Each flap 146 extends longitudinally from the distal end 140b towards the proximal end 140a. The flaps 146 taper towards the distal end 140b. The number of flaps 146 corresponds to the number of slots 144. The flaps 146 may be evenly or unevenly distributed. In an embodiment, the flaps 146 are formed integrally with the body of the inner jacket 140.
[0048] Fig. 5 depicts a perspective view of the outer shaft 300 of the deployment device 200, according to an embodiment of the present disclosure. The outer shaft 300 includes a proximal end at the proximal end 200a of the deployment device 200 and a distal end at the distal end 200b of the deployment device 200. The proximal end of the outer shaft 300 is removably coupled to the locking member 500 using a coupling technique including, but not limited to, snap-fit, threaded coupling micro-adhesive bonding, welding, etc. In an embodiment, the proximal end of the outer shaft 300 includes a plurality of outer threads 302 to couple with the locking member 500. In an embodiment, the distal end being in proximity with the implant 100.
[0049] According to an embodiment, the outer shaft 300 includes an elongated, tubular structure, defining an outer shaft lumen 300a. The outer shaft lumen 300a of the outer shaft 300 is configured to house the inner shaft 400 at least partially. In an embodiment, the diameter of the outer shaft lumen 300a is uniform i.e. the diameter of the outer shaft lumen 300a is same throughout the length of the outer shaft 300. Further, the diameter of the outer shaft lumen 300a may be equal to or greater than the diameter of the distal end of the inner shaft 400. The outer shaft 300 may include a predefined outer diameter, measured across the tubular body of the outer shaft 300. The outer diameter may be uniform or non-uniform, depending on procedural requirements. The outer diameter and the length of the outer shaft 300 may be chosen based on procedural requirements. The outer shaft 300 includes a predefined length ranging from 1300 mm to 2000 mm. The outer diameter of the outer shaft 300 may range between 0.20 mm to 5 mm. In an embodiment, the predefined length and the outer diameter of the outer shaft 300 are 1750 mm and 0.30 mm, respectively. The outer shaft 300 may be made of a suitable biocompatible material, including without limitation, stainless steel (316L), nitinol, platinum etc. In an embodiment, the outer shaft 300 is made of stainless steel (316L).
[0050] Fig. 6 depicts a perspective view of the inner shaft 400 of the deployment device 200, according to an embodiment of the present disclosure. The inner shaft 400 includes a proximal end at the proximal end 200a of the deployment device 200 and a distal end at the distal end 200b of the deployment device 200. The inner shaft 400 includes a flexible, elongated structure, allowing it to navigate through the tortuous and narrow pathways of the target site. The inner shaft 400 is at least partially disposed in the outer shaft lumen 300a of the outer shaft 300. In other words, the inner shaft 400 is operatively coupled to the outer shaft lumen 300a. The inner shaft 400 is configured to move axially within the outer shaft lumen 300a of the outer shaft 300 in response to actuation. The inner shaft 400 may include a hollow or solid core. In an embodiment, the inner shaft 400 includes a solid core.
[0051] The diameter and the length of the inner shaft 400 may be chosen based on procedural requirements. The length of the inner shaft 400 may range between 1500 mm and 1810 mm. In an embodiment, the length of the inner shaft 400 is 1795 mm. The inner shaft 400 may be made of a flexible biomaterial, including, but not limited to, stainless steel, nitinol, platinum, etc. In an embodiment, the inner shaft 400 is made of stainless steel (316L).
[0052] The proximal end of the inner shaft 400 is disposed within the locking member 500 towards the proximal end 200a of the deployment device 200. In an embodiment, the proximal end of the inner shaft 400 includes one or more stoppers 402 to be seated within the locking member 500. The stoppers 402 may be circular, rectangular, square, etc., depending on the procedural requirement for the coupling of the inner shaft 400 to the locking member 500. The one or more stoppers 402 of the inner shaft 400 temporarily lock with a distal end of the proximal portion 502a upon proximal movement of the locking member 500, resulting in deployment of the implant 100.
[0053] The distal end of the inner shaft 400 is positioned towards the distal end of the outer shaft 300 and is operatively coupled to the inner jacket 140 of the implant 100. In an embodiment, the distal end of the inner shaft 400 includes an anchor 404 and a rim 406. The anchor 404 is disposed at the extreme distal end of the inner shaft 400 and is configured to hold the implant 100 with the deployment device 200. In an embodiment, the anchor 404 tapers from its proximal end to its distal end. The diameter of the anchor towards its proximal end is more than the diameter of the inner shaft 400. The anchor 404 may include a hollow or solid core. In an embodiment, the anchor 404 includes a solid core. The anchor 404 facilitates easy transition from an undeployed state to a deployed state of the implant 100.
[0054] The rim 406 is positioned proximal to the proximal end of the anchor 404 at a pre-defined distance. The pre-defined distance between the anchor 404 and the rim 406 may depend upon factors such as the axial length of the distal portion 140d of the inner jacket 140 and the structural requirements for controlled decoupling of the implant 100. In an embodiment, the pre-defined distance is intentionally maintained between the anchor 404 and the rim 406 so that when the implant 100 is decoupled, the inner jacket 140 welded to the implant 100, is compressed easily. This facilitates precise decoupling of the implant 100 at the target site without requiring excessive force and simultaneously provides additional backup to keep the implant 100 securely coupled during navigation. The pre-defined distance between the anchor 404 and the rim 406 may range between 1 mm to 5. In an embodiment, the pre-defined distance between the anchor 404 and the rim 406 is 1 mm.
[0055] The rim 406 is configured to retain a distal portion 140d of the inner jacket 140 during navigation. The inner jacket lumen 142 receives the distal end of the inner shaft 400. The distal end 140b of the inner jacket 140 is coupled to the rim 406. The rim 406 exerts a retaining force on the distal end 140b, keeping the inner jacket 140 in place during navigation. The slots 144 of the inner jacket 140 radially expand when the inner shaft 400 is pulled in the proximal (upward) direction. In the deployed state, when the inner shaft 400 is pulled proximally, the rim 406 pushes against the distal portion 140d of the inner jacket 140. For example, the rim 406 pushes against the distal end of the flaps 146 causing the flaps 146 to expand. This creates a passage for the rim 406 and anchor 404 of the inner shaft 400. The rim 406 along with the anchor 404 can be pulled proximally, decoupling the inner shaft 400 and the implant 100.
[0056] Fig. 7A– Fig. 7C depict various views of the locking member 500 of the deployment device 200, according to an embodiment of the present disclosure. The locking member 500 is disposed at the proximal end 200a of the deployment device 200. The locking member 500 is configured to removably couple to the outer shaft 300 of the deployment device 200. The locking member 500 serves as a secure connection interface to control the movement of the inner shaft 400 while also permitting easy decoupling when required. The locking member 500 may have a shape, such as, without limitation, cuboidal, cylindrical, etc.
[0057] In an embodiment, the locking member 500 includes a cylindrical tubular structure, defining a lumen 502. The lumen 502 is configured to house at least a portion of the proximal end of the inner shaft 400. The locking member 500 may be made of a biocompatible material, including, without limitation, stainless steel, nitinol, platinum, etc. In an exemplary implementation, the locking member 500 is made of stainless steel (316L). The length of the locking member 500 may be chosen based on procedural requirements. The length of the locking member 500 may range between 30 mm and 100 mm. In an embodiment, the length of the locking member 500 is 50 mm. The outer diameter of the locking member 500 may be chosen based on the outer diameter of the outer shaft 300. The outer diameter of the locking member 500 may range between 0.10 mm and 0.40 mm. In an embodiment, the outer diameter of the locking member 500 is 0.30 mm.
[0058] The locking member 500 includes a proximal end 500a towards the proximal end 200a of the deployment device 200 and a distal end 500b towards the distal end 200b of the deployment device 200. The lumen 502 extends between a proximal end 500a and a distal end 500b of the locking member 500. In an embodiment, the lumen 502 includes three portions: a proximal portion 502a, an intermediate portion 502b, and a distal portion 502c, as shown in Fig. 7C.
[0059] The proximal portion 502a of the lumen 502 is positioned towards the proximal end 500a of the locking member 500 and includes a first diameter. The intermediate portion 502b, located distal to the proximal portion 502a and includes a second diameter. The first diameter is relatively larger compared to the second diameter, forming a step between the two regions. In other word, the second diameter of the intermediate portion 502b is smaller than the first diameter. The width of the stoppers 402 is greater than that of the second diameter of the intermediate portion 502b. This allows the stoppers 402 to rest against the step during the proximal movement of the inner shaft 400. The distal portion 502c of the lumen 502 includes a third diameter. The third diameter greater than the first diameter, i.e., the third diameter is largest diameter among the three portions. The third diameter includes a plurality of inner threads 502c1 on its inner surface.
[0060] The proximal portion of the inner shaft 400 is movably disposed in the proximal portion 502a of the lumen 502. In an embodiment, both the proximal portion 502a and the intermediate portion 502b of the lumen 502 have smooth inner surfaces, allowing free axial movement of the inner shaft 400. The distal portion 502c is threaded to facilitate a secure yet removable coupling between the locking member 500 and the outer shaft 300. In other words, the outer shaft 300 and the locking member 500 are coupled via a threaded connection. In an embodiment, the plurality of inner threads 502c1 of the distal portion 502c are configured to engage with the outer threads 302 provided on the proximal end of the outer shaft 300. The diameters of the proximal portion 502a, intermediate portion 502b and distal portion 502c may range from 0.20 mm to 0.30 mm, 0.15 mm to 0.25 mm and 0.20 mm to 0.30 mm, respectively. In an embodiment, the diameters of the proximal portion 502a, the intermediate portion 502b and the distal portion 502c are 0.22 mm, 0.18 mm and 0.25 mm, respectively.
[0061] The locking member 500 is configured to control the axial movement of the inner shaft 400. Fig. 8A depicts the arrangement of the components in a threaded state. In the threaded state, the inner threads 502c1 of the distal portion 502c of the lumen 502 engage with the outer threads 302 of the outer shaft 300, securing the locking member 500 to the outer shaft 300. While the locking member 500 is in the threaded state, the axial movement of the inner shaft 400 is constrained, and the anchor 404 of the inner shaft 400 extends distally outside the distal end of the outer shaft 300. The anchor 404 and rim 406 extend beyond the distal end of the flap 146 and into the coil 120. Further, the stoppers 402 of the inner shaft 400 resides freely at an intermediate position in the proximal portion 502a of the lumen 502. Thus, the implant 100 remains in an undeployed state, coupled to the anchor 404 via the inner jacket 140.
[0062] In an unthreaded state depicted in Fig. 8B, the locking member 500 is disengaged from the inner threads 502c1 from the outer threads 302 of the outer shaft 300. Once disengaged, the locking member 500 can be pulled proximally by a pre-defined distance (W) relative to the outer shaft 300 causing one or more stoppers of the inner shaft 400 to temporarily lock with a distal end of a proximal portion of the locking member 500.
[0063] Upon further application of the proximal pulling force on the locking member 500, the inner shaft 400 moves proximally within the outer shaft lumen. When the inner shaft 400 is pulled proximally, the flaps 146 experience an outward force. Due to this, the flaps 146 expand into the slots 144 in the distal portion 140d of the inner jacket 140. The inner jacket 140 thus decouples from the inner shaft 400.
[0064] Due to this expansion, the anchor 404 of the inner shaft 400 retracts into the outer shaft lumen 300a of the outer shaft 300 and resides within the distal end of the outer shaft 300. This decouples the implant 100 with the deployment device 200, facilitating the release and deployment of the implant 100 at the target site. The predefined distance (W) between the locking member 500 and the outer shaft 300 may range from 2 mm to 7 mm. In an embodiment, the predefined distance (W) is 3 mm.
[0065] While the depicted embodiment of the deployment device 200 includes the inner shaft 400, outer shaft 300, inner jacket 140, outer jacket 130, and the locking member 500 in a specific configuration, a person skilled in the art will appreciate that numerous variations in the arrangement, inclusion, or exclusion of these components may be implemented while preserving the core functionality of precise coil deployment. These alternatives remain within the scope of the present disclosure.
[0066] Fig. 9 depicts a flowchart of a method 900 of decoupling an implant 100 from a deployment device 200. At step 902, the deployment device 200 includes the anchor 404 of the inner shaft 400 at least partially disposed within the implant 100, and one or more stoppers 402 at its proximal end. The inner shaft 400 is at least partially disposed within the implant 100. A locking member 500 is coupled to the distal end of an outer shaft 300 via threaded engagement.
[0067] At step 904, the locking member 500 is disengaged from the outer shaft 300. In an embodiment, disengaging includes unthreading inner threads 502c1 of the locking member 500 from outer threads 302 of the outer shaft 300.
[0068] At step 906, the locking member 500 is pulled proximally by a predefined distance (W) relative to the outer shaft 300. During this movement, one or more stoppers 402 of the inner shaft 400 temporarily lock with a step formed at the distal end of a proximal portion 502a of the lumen 502 within the locking member 500.
[0069] At step 908, the locking member 500 is further pulled proximally beyond the predefined distance (W), resulting in the axial retraction of the inner shaft 400 relative to the outer shaft 300.
[0070] At step 910, the implant 100 is decoupled from the inner shaft 400. The radial expansion of flaps 146 on the distal portion 140d allows the inner jacket 140 to detach from the inner shaft 400, thereby deploying the implant 100 at the target site.
[0071] The proposed deployment device presents several advantages over the conventional deployment device. The mechanical coupling between the rim, the inner jacket, and the outer jacket enables precise and controlled decoupling. The design ensures that the coil is only deployed upon deliberate retraction of the inner shaft, reducing the risk of non-target embolization. Moreover, the use of the locking member provides a secure and reliable mechanism to lock or unlock the system, enhancing operator control during the deployment procedure. This configuration allows for a smooth transition from navigation to deployment, ensuring safe and accurate coil placement within the vasculature.
[0072] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM
1. An implant (100) comprising:
a. a coil (120) that extends from a proximal end (100a) to a distal end (100b); and
b. an inner jacket (140) coupled to a proximal end of the coil (120), the inner jacket (140) configured to operatively couple to a deployment device, including:
i. a plurality of slots (144) provided at a distal portion (140d) of the inner jacket (140); and
ii. a plurality of flaps (146) provided at the distal portion (140d), with a flap (146) of the plurality of flaps (146) alternating with a slot (144) of the plurality of slots (144);
wherein the flaps 146 are configured to radially expand to decouple the implant 100 from the deployment device for deployment at a target site.
2. The implant (100) as claimed in claim 1, wherein the implant (100) includes an outer jacket (130) coupled to a proximal portion (140c) of the inner jacket (140).
3. An implant (100) comprising:
a. a coil (120) that extends from a proximal end (100a) to a distal end (100b);
b. an outer jacket 130 coupled to a proximal end of the coil 120; and
c. an inner jacket (140) coupled to a proximal end of the coil (120), the inner jacket (140) configured to operatively couple to a deployment device, including:
i. a plurality of slots (144) provided at a distal portion (140d) of the inner jacket (140); and
ii. a plurality of flaps (146) provided at the distal portion (140d), with a flap (146) of the plurality of flaps (146) alternating with a slot (144) of the plurality of slots (144);
wherein the flaps 146 are configured to radially expand to decouple the implant 100 from the deployment device for deployment at a target site.
4. The implant (100) as claimed in claim 1 or 3, wherein the coil (120) is made of one or more biocompatible materials including platinum, platinum-tungsten, platinum-iridium, tungsten, stainless steel, nitinol, and nickel-titanium.
5. The implant (100) as claimed in claim 1 or 3, wherein at least one of the inner jackets (140) and the outer jacket (130) is made of one or more biocompatible materials including platinum, stainless steel, inconel (nickel-based superalloy), and nitinol (nickel-titanium alloy).
6. The implant (100) as claimed in claim 1 or 3, wherein the implant (100) includes a cap (100c) coupled to the distal end of the coil (120) and configured to facilitate smooth navigation of the implant (100).
7. The implant (100) as claimed in claim 6, wherein the cap (100c) is made of one or more biocompatible materials, including silicone rubber, thermoplastic elastomer, hydrogel, n-butyl cyanoacrylate (NBCA), nylon, polyethylene terephthalate, polyester, silk, polyvinyl alcohol (PVA), and soft polymer.
8. A deployment device (200) for deploying an implant (100), the deployment device (200) comprising:
a. an outer shaft (300) including an outer shaft lumen (300a), a proximal end and a distal end, the distal end being in proximity with an implant (100);
b. an inner shaft (400) operatively coupled to the outer shaft lumen (300a), the inner shaft (400) includes an anchor (404) at its distal end to hold the implant (100) and one or more stoppers (402) at its proximal end; and
c. a locking member (500) removably coupled to the proximal end of the outer shaft (300), the locking member (500) including a lumen (502) having a proximal portion (502a);
wherein a proximal portion of the inner shaft (400) is movably disposed in the proximal portion (502a) of the lumen (502);
wherein the one or more stoppers (402) of the inner shaft (400) temporarily lock with a distal end of the proximal portion (502a) upon proximal movement of the locking member (500), resulting in deployment of the implant (100).
9. The deployment device (200) as claimed in claim 8, wherein the outer shaft (300) and the locking member (500) are coupled via a threaded connection.
10. The deployment device (200) as claimed in claim 8, wherein the inner shaft (400) includes a rim (406) positioned proximal to the anchor (404), the rim (406) configured to retain a distal portion (140d) of the inner jacket (140) during navigation.
11. The deployment device (200) as claimed in claim 8, wherein the proximal portion (502a) of the lumen (502) of the locking member (500) includes a first diameter, the lumen (502) further comprises:
a. an intermediate portion (502b) having a second diameter smaller than the first diameter, and
b. a distal portion (502c) having a third diameter greater than the first diameter.
12. A method (900) of decoupling an implant (100) from a deployment device (200), comprising:
a. providing a deployment device (200) comprising an anchor (404) of an inner shaft (400) at least partially disposed within the implant (100) and a locking member (500) coupled to a distal end of an outer shaft (300);
b. disengaging the locking member (500) from the outer shaft (300);
c. pulling the locking member (500) proximally by a predefined distance (W) relative to the outer shaft (300), causing one or more stoppers of the inner shaft (400) to temporarily lock with a distal end of a proximal portion of the locking member (500);
d. further pulling the locking member (500) proximally beyond the predefined distance (W) relative to the outer shaft (300) causing retraction of the inner shaft (400); and
e. decoupling the implant (100) from the inner shaft (400) for deployment at a target site.
13. The method (900) as claimed in claim 12, wherein the disengaging includes disengaging the locking member (500) by unthreading inner threads (502c1) of the locking member (500) from outer threads (302) of the outer shaft (300).