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 DELIVERING GLAUCOMA EYE STENT

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 DISCLOSURE
[1] The present disclosure relates to a medical device. More particularly, the present disclosure relates to a delivery device for delivering glaucoma eye stents.
BACKGROUND OF DISCLOSURE
[2] Aqueous humor is a fluid produced by the ciliary body, essential for maintaining the shape of the eye, nourishing its internal structures, and regulating intraocular pressure (IOP), as shown in Fig. 1. It circulates through the anterior and posterior chambers before draining through the trabecular meshwork and Schlemm's canal. This process maintains normal IOP, crucial for eye health.
[3] In glaucoma, this drainage system is blocked or impaired, causing fluid buildup and increased IOP. Elevated pressure compresses the optic nerve, leading to gradual vision loss, typically starting with peripheral vision. As the disease often develops without symptoms, regular eye exams are vital for early detection.
[4] For patients where treatments such as medicated eye drops, laser therapy, or other interventions fail to adequately reduce IOP, glaucoma stents provide a surgical alternative. The glaucoma stent is a small implant also known as glaucoma drainage device. It helps to establish an alternative outflow pathway for aqueous humor, effectively bypassing the impaired trabecular meshwork and Schlemm’s canal. By diverting excess fluid either to an external reservoir or the subconjunctival space, these devices assist in lowering IOP and mitigating further optic nerve damage.
[5] The implantation of a glaucoma stent, such as a micro-sized stent (e.g., iStent), is a minimally invasive procedure and requires a delivery system. The glaucoma stent is pre-loaded into the delivery system, allowing the surgeon to introduce the device through a small incision. Once the delivery device is positioned inside the eye, the surgeon deploys the stent into the drainage system (trabecular meshwork), which facilitates the outflow of aqueous humor to reduce intraocular pressure.
[6] However, a persistent challenge with the conventional delivery device is the potential migration or dislodgement of the stent from the delivery system before it is implanted. During the critical stages of the delivery and positioning, unintended movement of the stent may occur due to insufficient control or stabilization within the delivery system. This may result in a premature release of the stent, a misalignment of the stent with the target tissue, or even a complete loss of the stent within the anterior chamber.
[7] Such a migration event complicates the surgical procedure, requiring repositioning or retrieval of the stent, and can increase the risk of trauma to intraocular structures. Inconsistent placement may also lead to suboptimal performance in reducing IOP, potentially necessitating further surgical intervention.
[8] Hence, there is a need to develop a delivery device for delivering glaucoma stents that overcomes the aforementioned problems.
SUMMARY OF DISCLOSURE
[9] 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.
[10] The present disclosure relates to a device. The device includes an actuator, a coupling assembly, a first tube and a needle. The actuator is configured to receive at least a first trigger and a second trigger. In an embodiment, the coupling assembly includes a first support plate, a second support plate, and at least one resilient member. The first support plate and the second support plate are coupled to the actuator. The second support plate is configured to move in a distal direction in response to the first trigger. The at least one resilient member is coupled to the first support plate. The at least one resilient member is configured to apply a resilient force to push the first support plate in a proximal direction. The first tube is coupled to the first support plate. The first tube is configured to cover one or more glaucoma stents in an initial configuration. The needle includes a needle tip. The needle is coupled to the second support plate. The needle is configured to hold the one or more glaucoma stents. Wherein, on receipt of the first trigger, the first tube and the needle are configured to move in the distal direction. Wherein, on receipt of the first trigger, the first tube and the needle are configured to move in the distal direction. Wherein, upon release of the first trigger, the first tube is configured to retract with respect to at least a portion of the needle, exposing a first stent of the one or more stents out of the first tube. Wherein, on receipt of the second trigger, the first tube is configured to push the exposed first stent to the needle tip.
BRIEF DESCRIPTION OF DRAWINGS
[11] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[12] Fig. 1 depicts anatomical structures of an eye.
[13] Fig. 2a depicts a perspective view of a device 200, according to an embodiment of the present disclosure.
[14] Figs. 2b-2e depict perspective views of a plurality of tubes of the device 200, according to an embodiment of the present disclosure.
[15] Figs. 3a-3b depict assembled view of various components of a handle 300 of the device 200, according to an embodiment of the present disclosure.
[16] Fig. 3c depict exploded views of an assembly inside the handle 300 of the device 200, according to an embodiment of the present disclosure.
[17] Fig. 3d depict coupling between an actuator 302, a gear assembly and a cam assembly, according to an embodiment of the present disclosure.
[18] Fig. 3e depicts coupling between a follower 312 of the cam assembly and a block 318, according to an embodiment of the present disclosure.
[19] Figs. 3f-3g depict the block 318 and coupling between the block 318 and the follower 312, according to an embodiment of the present disclosure.
[20] Fig. 3h depicts a slab disposed between a first support plate 330 and a second support plate 332 of the block 318 and coupling of a first tube 350, a second tube 360 and a needle 400 with the first support plate 330, the slab 80 and the second support plate 332, respectively, according to an embodiment of the present disclosure.
[21] Figs. 3i-3j depict coupling of the follower 312 and a second support plate 332 with the handle 300, according to an embodiment of the present disclosure.
[22] Figs. 4a-4c depict coupling between a first support plate 330 of the block 318 and a holder plate 345, according to an embodiment of the present disclosure.
[23] Fig. 5 depicts a third tube 370 and a fourth tube 380 of the plurality of tubes coupled to a holder plate 345 of the device 200, according to an embodiment of the present disclosure.
[24] Fig. 6 depicts a flowchart of a method 600 of operating the device 200, according to an embodiment of the present disclosure.
[25] Figs. 7a-7b depict arrangement of the needle 400, the plurality of tubes and various components of the coupling assembly at an initial stage, according to an embodiment of the present disclosure.
[26] Figs. 8a-8b depict arrangement of the needle 400, the plurality of tubes and various components of the coupling assembly in response to a first trigger, according to an embodiment of the present disclosure.
[27] Figs. 9a-9b depict arrangement of the needle 400, the plurality of tubes and various components of the coupling assembly in response to release of the first trigger, according to an embodiment of the present disclosure.
[28] Figs. 10a-10b depict arrangement of the needle 400, the plurality of tubes and various components of the coupling assembly in response to a second trigger, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[29] 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.
[30] 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.
[31] 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.
[32] Furthermore, the described includes, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific includes or advantages of a particular embodiment. In other instances, additional includes and advantages may be recognized in certain embodiments that may not be present in all embodiments. These includes and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[33] This current disclosure pertains to a delivery device (or device). The device is used in ophthalmic surgeries, particularly in delivery of a glaucoma stent in the eye's drainage system for the treatment of glaucoma. The device includes a needle and a plurality of tubes. In an embodiment, the plurality of tubes includes an inner tube, an outer tube and at least one intermediate tube disposed therebetween. The needle is disposed in the inner tube of the plurality of tubes. One or more glaucoma stents (interchangeably referred to as stents) are pre-loaded on the needle and are covered by the at least one intermediate tube before the insertion and/or deployment of the stent. This eliminates the risk of migration of the stent during insertion or before deployment, ensuring consistent clinical outcomes.
[34] In an embodiment, the device includes an actuator configured to control the advancement and retraction of the needle and the at least one intermediate tube of the plurality of tubes for delivering the glaucoma stent. The device is designed to deliver one or more stents in a controlled and sequential manner during a single surgical intervention. This allows the surgeon to deploy several stents without having to repeatedly withdraw and reinsert separate devices, thereby simplifying the overall procedure. By enabling consecutive delivery of multiple stents, the device improves surgical workflow, reduces operative time, and enhances placement accuracy. The delivery system enables precise alignment of the stent within the target anatomical site. The actuator provides the user with a complete control over stent deployment, allowing precise and controlled delivery of the stent as per the user’s requirements. It is engineered to prevent damage to the canal wall, reducing complications and enhancing patient safety.
[35] Additionally, the device helps to maintain a more stable surgical environment, minimizing the risk of tissue disruption or trauma associated with multiple device exchanges. Further, the device is intended to provide a more efficient, safer, and cost-effective method for addressing conditions that require multi-stent placement. Additionally, the compact and ergonomic configuration of the device supports minimally invasive procedures and enhances surgeon handling. The device is designed with a compact profile, making it fully compatible with micro incision. This reduces surgical trauma and leads to faster recovery of patients.
[36] The device is designed for single-handed use, incorporating an ergonomic grip to facilitate ease of handling. This allows the surgeon to maintain control while using the other hand for gonioscopic visualization or other instruments. In an embodiment, the device is intended for single use (disposable), hence, ensures hygienic application and eliminates the need for post-operative reprocessing.
[37] Now referring to figures, Fig. 2a illustrates a delivery device 200, according to an embodiment of the present disclosure. The device 200 is used for delivering one or more glaucoma stents 500 (hereinafter, stents 500) in the eye's drainage system. The device 200 has a proximal end 200a and a distal end 200b. The proximal end 200a of the device 200 refers to an end of the device 200 closest to the operator, typically remaining outside the patient's body for handling, control, or connection to other devices. The distal end 200b is an end of the device 200 farthest from the operator, designed to be inserted into the patient's body to reach a target site for diagnosis or treatment. In an embodiment, the device 200 includes a handle 300, a needle 400 and a plurality of tubes coupled to the handle 300.
[38] The handle 300 allows a user to hold the device 200. The handle 300 has a proximal end 300a and a distal end 300b. The handle 300 is ergonomically designed for easier operation. In an embodiment depicted in Fig. 2, the handle 300 is generally conical in shape (i.e., a body of the handle 300 gradually tapers from the distal end 300b towards the proximal end 300a). While the handle 300 is depicted herein as having a conical shape, a person skilled in the art will appreciate that numerous variations to the shape of the handle 300 may be made while performing the inventive features of the present disclosure, and the same is within the scope of the present disclosure.
[39] In an embodiment, the handle 300 includes an actuator 302 and a coupling assembly. The coupling assembly is disposed within the handle 300. The coupling assembly helps in coupling the actuator 302 with the plurality of tubes and the needle 400. The actuator 302 helps in delivering the one or more stents 500 at the target site, which has been explained later. The actuator 302 is configured to receive at least a first trigger and a second trigger. In an embodiment, the actuator 302 is a rotatable knob. The actuator 302 is rotatable in a first predefined direction to deliver the stent 500 in the target region. In this case, the first trigger comprises a first rotation of the actuator 302 in the first predefined direction and the second trigger comprises a second rotation of the actuator 302 in the first predefined direction. The first predefined direction may be one of a clockwise direction or an anticlockwise direction. In an embodiment, the actuator 302 is configured to rotate in the clockwise direction. In an embodiment, the actuator 302 includes a peripheral surface that may be textured or contoured to provide a better grip to the user. It should be appreciated that the actuator 302 including the rotating knob as described herein is merely exemplary. The actuator 302 may be implemented in any other form (e.g., the actuator 302 may be a sliding button).
[40] The plurality of tubes includes an outer tube, an inner tube and at least one intermediate tube disposed therebetween. In an embodiment, the plurality of tubes includes a first tube 350, a second tube 360, a third tube 370, as shown in Figs. 2b-2c. Each tube includes a respective proximal end and a respective distal end, thereby defining a respective length. The plurality of tubes is coupled to the handle 300 and/or one or more components of the coupling assembly as explained later.
[41] The first tube 350 has a proximal end 350a and a distal end 350b. In an embodiment, the first tube 350 (as shown in Fig. 2b) has a uniform tubular structure, though it may have a stepped configuration. The first tube 350 includes a groove 350d at the proximal end 350a. The groove 350d is provided for coupling the first tube 350 with the coupling assembly in the handle 300 (explained later). In an embodiment, the first tube 350 includes a tapered portion 350c at the distal end 350b, as shown in Fig. 2e. A diameter of the tapered portion 350c decreases from a proximal to a distal end of the tapered portion 350c. The tapered portion 350c helps in delivering the stents 500. The first tube 350 may be made of a material, such as, without limitation nitinol, stainless steel (SS 316L), titanium, etc. In an embodiment, the first tube 350 is made of nitinol. The length of the first tube 350 may range between 20 mm and 80 mm. In an embodiment, the length of the first tube 350 is 54.5 mm. An outer diameter of the first tube 350 may range between 0.2 mm and 01 mm. In an embodiment, the outer diameter of the first tube 350 is 0.5 mm. A diameter of the tapered portion 350c at the distal end 350b is smaller than the outer diameter. The tapered portion 350c includes a maximum diameter and a minimum diameter at a proximal end and a distal end, respectively, of the tapered portion (350c). The maximum diameter at the proximal end of the tapered portion 350c corresponds to the outer diameter of the first tube 350 at the distal end 350b. The minimum diameter at the distal end of the tapered portion 350c is smaller than a diameter at the proximal end of the stent 500. The diameter of the tapered portion 350c at the distal end 350b may range between 0.05 mm and 0.2 mm. In an embodiment, the diameter of the tapered portion 350c at the distal end 350b is 0.1 mm. In an embodiment, the first tube 350 is configured to move axially (e.g., in the proximal and distal direction) in response to the rotation of the actuator 302, which has been explained later.
[42] The first tube 350 is hollow from inside, thereby defining a first lumen (not shown). The first lumen of the first tube 350 is configured to receive the second tube 360.
[43] The second tube 360 is disposed inside the first tube 350. The second tube 360 has a uniform tubular structure. The second tube 360 has a proximal end 360a and a distal end 360b. A partial length of the second tube 360 is disposed within the first lumen of the first tube 350 (as shown in Figs. 2b-2c). In an embodiment, the distal end 360b resides within the first tube 350 and the proximal end 360a extends out of the first tube 350 in a proximal direction. An outer diameter of the second tube 360 corresponds to a diameter of the first lumen of the first tube 350. The outer diameter of the second tube 360 may range between 0.22 mm and 0.52 mm, respectively. In an embodiment, the outer diameter of the second tube 360 is 0.31 mm. The second tube 360 may have a length ranging between 50 mm and 100 mm. In an embodiment, the length of the second tube 360 is 56.86 mm. The second tube 360 remains stationary with respect to the axial movement of the first tube 350.
[44] The second tube 360 may be made of materials, such as, without limitation, stainless steel, nitinol, or other biocompatible metals and alloys, etc. In an embodiment, the second tube 360 is made of stainless steel. In an embodiment, the second tube 360 is the inner tube of the plurality of tubes. The second tube 360 generally has a hollow tubular structure, thereby defining a second lumen (not shown). The second lumen is configured to receive the needle 400.
[45] The needle 400 has a proximal end 400a and a distal end 400b (as shown in Fig. 2b). The needle 400 is partially disposed within the second tube 360 such that the proximal end 400a and the distal end 400b of the needle 400 extends out of the second tube 360 in a proximal and distal direction, respectively. Further, a part of the needle 400 towards the distal end 400b resides within the first lumen of the first tube 350 as shown in Fig. 2c. The distal end 400b of the needle 400 protrudes out of the first tube 350 in the distal direction.
[46] The needle 400 includes a distal tip 400c at the distal end 400b (as shown in Fig. 2d). The distal tip 400c may be tapered or beveled. In an embodiment, the distal tip 400c has a tapered design. The distal tip 400c facilitates smooth penetration of the needle 400 through the trabecular meshwork and into the Schlemm’s canal. The distal tip 400c allows for minimally invasive access through the anterior chamber and accurate placement of the stent 500 at the target site. The needle 400 is configured to hold the one or more glaucoma stents 500. The needle 400 is configured to move axially in the distal direction in response to the rotation of the actuator 302.
[47] The needle 400 may have a length ranging between 50 mm and 100 mm. In an embodiment, the length of the needle 400 is 66.8 mm. A diameter of the needle 400 corresponds to a diameter of the second lumen of the second tube 360. The diameter of the needle 400 may range between 0.05 mm and 0.1 mm. In an embodiment, the diameter of the needle 400 is 0.08 mm. The needle 400 may be made of a material, such as, without limitation stainless steel, nitinol, or other biocompatible metals and alloys, etc. In an embodiment, the needle 400 is made of nitinol.
[48] In an embodiment, the first tube 350 is partially disposed within the third tube 370 (as shown in Figs. 2b-2c). The third tube 370 is immovable with respect to the axial movement of the first tube 350. In other words, the third tube 370 remains stationary during the operation of the device 200. The third tube 370 may have a uniform tubular structure extending between a proximal end 370a and a distal end 370b of the third tube 370. In an embodiment, the third tube 370 includes a groove 370d provided towards the proximal end 370a. The groove 370d is provided for coupling the third tube 370 with a component of the coupling assembly (explained later). The length of the third tube 370 may range between 20 mm and 65 mm. In an embodiment, the length of the third tube 370 is 24 mm. The third tube 370 may be made of material, such as, without limitation nitinol, stainless steel (SS 316L). In an embodiment, the third tube 370 is made of nitinol. The third tube 370 is hollow from inside and defines a third lumen (not shown), within which the first tube 350 is disposed. In an embodiment, the third tube 370 is the outer tube of the plurality of tubes.
[49] In an embodiment, the plurality of tubes, optionally, includes a fourth tube 380 disposed between the first tube 350 and the third tube 370. Thus, the first tube 350 corresponds to a first intermediate tube and the fourth tube 380 corresponds to a second intermediate tube of the plurality of tubes. The fourth tube 380 is inserted into the eye. The fourth tube 380 acts as a trocar, provides a stable, sealed access port into the eye and prevents damage to the canal wall, thereby reducing complications and enhancing patient safety. The fourth tube 380 remains stationary with respect to the movement of the first tube 350. In an embodiment, a partial length of the fourth tube 380 is disposed within the third lumen of the third tube 370 such that the proximal end 380a resides within the third lumen of the third tube 370 and distal end 380b extends beyond the distal end 370b in the distal direction. Further, the distal end 380b is disposed proximal to the distal end 350b of the first tube 350. In an embodiment, the fourth tube 380 includes a bevel structure at the distal end 380b. The bevel structure facilitates a controlled incision through the corneal layer. In an embodiment, an outer diameter of the fourth tube 380 corresponds to a diameter of the third lumen of the third tube 370. The outer diameter of the fourth tube 380 may range between 0.5 mm and 2 mm. In an embodiment, the outer diameter of the fourth tube 380 is 1 mm. In an embodiment, the length of the fourth tube 380 is more than the length of the third tube 370. The length of the fourth tube 380 may range between 20 mm and 70 mm. In an embodiment, the length of the fourth tube 380 is 45 mm. the fourth tube 380 may be made of a material, such as, without limitation stainless steel, titanium, or other biocompatible metals, etc. In an embodiment, the fourth tube 380 is made of stainless steel.
[50] As shown in Figs. 2d-2e, in an embodiment, the glaucoma stents 500 (hereinafter, stents 500) are disposed on a distal portion of the needle 400. For example, two stents 500, namely, a first stent 500a and a second stent 500b, are mounted on the needle 400. The first stent 500a is distal to the second stent 500b. It should be appreciated that the number of stents 500 mounted on the needle 400 may be less than or more than two and is decided based upon procedural requirements. Further, the stents 500 illustrated herein are merely exemplary. The device 200 is capable of delivering glaucoma stents of any other design and the same is within the scope of the present disclosure.
[51] Each stent 500 includes a proximal end and a distal end, thereby defining a length. The dimensions of the stent 500 may be chosen based upon the patient’s anatomy and needs. The length of the stent 500 may range between 0.3 mm and 0.4 mm. A proximal diameter (i.e., the diameter of the stent 500 at the proximal end) is larger than a distal diameter (i.e., the diameter of the stent 500 at the distal end). The proximal diameter and the distal diameter may range between 0.2 mm and 0.4 mm, and 0.1 mm and 0.2 mm, respectively. In an embodiment, the proximal diameter and the distal diameter of the stent 500 are 0.36 mm and 0.1 mm, respectively. The stent 500 may be made of material, such as, without limitation stainless steel, titanium, or other biocompatible metals etc. In an embodiment, the stent 500 is made of stainless steel.
[52] The one or more stents 500 are covered by the at least one intermediate tube before the insertion and/or deployment (i.e., in an undeployed state) of the stent the plurality of tubes. For example, the first tube 350 is configured to cover the stents 500 in an initial configuration (also referred to as an initial stage). In response to the axial movement of the at least one intermediate tube of the plurality of tubes, the stent 500 is exposed out of the intermediate tube and is delivered at the distal tip 400c of the needle 400, which has been explained later.
[53] In an embodiment, the one or more stents 500 are covered by the first tube 350 in the undeployed state. In response to the axial movement of the first tube 350, the stents 500 are sequentially exposed out of the first tube 350. For example, a distal-most stent (the first stent 500a in the depicted example) is exposed and delivered first followed by a stent 500 proximally adjacent to the distal-most stent 500 (the second stent 500b in the depicted example), and so on. The diameter of the tapered portion 350c at the distal end 350b of the first tube 350 is less than or equal to the proximal diameter of the stent 500. The tapered portion 350c expands to expose the stent 500 as it moves in the proximal direction. And, returns to its original shape when the tapered portion 350c is positioned at a proximal end of the first distal-most stent 500, thus exposing the first distal-most stent 500 out of the first tube 350. The tapered portion at the distal end 350b of the first tube 350 restricts the exposed distal-most stent 500 from re-entering the first tube 350 after being exposed. This is due to the smaller diameter of the tapered portion 350c at the distal end 350b than the proximal diameter of the stent 500. Similarly, subsequent stents 500 are exposed out of the first tube 350. The first tube 350 prevents the risk of migration during insertion or before deployment, ensuring consistent clinical outcomes.
[54] The stents 500 are positioned on the needle 400 distal to the second tube 360, such that the distal end 360b of the second tube 360 abuts a proximal end of a proximal-most stent 500 (the second stent 500b in the depicted example), as shown in Fig. 2e. In an embodiment, the diameter of the second tube 360 is smaller than a diameter of the stent 500. Therefore, the second tube 360 acts as a stopper and is configured to restrict proximal movement of the stents 500 during the delivery of the stents 500, e.g., during the movement of the first tube 350.
[55] Figs. 3a-3c depict the coupling assembly, according to an embodiment of the present disclosure. The coupling assembly is disposed or housed within the handle 300 towards the distal end 300b, as shown in Fig. 3a. In an embodiment, the coupling assembly includes a cam assembly, a gear assembly, a block 318, and at least one resilient member 340, as shown in Figs. 3b-3c.
[56] The actuator 302 is coupled to the cam assembly with the help of the gear assembly. In an embodiment, the cam assembly includes a cam 310 and a follower 312. The cam 310 is coupled to the actuator 302 via the gear assembly.
[57] The gear assembly provides torque to the cam 310. The gear assembly may include bevel gears, spur gears, etc., coupled to each other. In an exemplary embodiment, the gear assembly is a spur gear assembly and includes a first gear 304 and a second gear 306 coupled to each other, as shown in Fig. 3d.
[58] The first gear 304 includes a first shaft 304a and a plurality of first teeth 304b (hereinafter, first teeth 304b). The first shaft 304a of the first gear 304 may be coupled to the actuator 302 using techniques, such as, without limitation adhesive bonding, press fitting, keyway, set screw, etc. In an embodiment, the first shaft 304a is coupled to the actuator 302 using adhesive bonding technique. The first teeth 304b may have a predefined profile, e.g., spiral, straight, helical, etc. In an example implementation, the first teeth 304b have a straight profile.
[59] The second gear 306 has a cylindrical body having a first end 306a and second end 306b. The first end 306a of the second gear 306 may be coupled to the cam 310 using, for example, press fitting, keyway, splined connection or set screw techniques. In an embodiment, the first end 306a of the second gear 306 and the cam 310 form an integrated structure, i.e., the second gear 306 and the cam 310 are integrally coupled. Further, the second gear 306 includes a plurality of second teeth 306c provided at the second end 306b. The second teeth 306c may have a predefined profile, e.g., spiral, straight, helical, etc. In an example implementation, the second teeth 306c have a straight profile. The second teeth 306c are configured to engage with the first teeth 304b. The second gear 306 is rotatably coupled to the first gear 304 via respective teeth (i.e., the first teeth 304b and the second teeth 306c) such that rotational axes of the first gear 304 and the second gear 306 make a predefined angle. In an embodiment, the rotational axes of the first gear 304 and the second gear 306 are perpendicular to each other.
[60] The first gear 304 and the second gear 306 may have a respective diameter, ranging between 8 mm and 15mm, and 10mm and 22mm, respectively. In an embodiment, the diameter of the first gear 304 and the second gear 306 are 10mm and 18mm, respectively. The first gear 304 and the second gear 306 may be made of material, such as, without limitation, stainless steel (SS 316), brass, aluminum, etc., or a combination thereof. The first gear 304 and the second gear 306 may be made of same or different material. In an embodiment, the first gear 304 and the second gear 306 are made of stainless steel (SS 316), and aluminum, respectively.
[61] The first gear 304 is configured to rotate in response to the rotation of the actuator 302. The rotational direction of the first gear 304 is same as the rotational direction of the actuator 302. The first gear (304) configured to rotate in the first direction upon receiving the first trigger and the second trigger. In response to the rotation of the first gear 304 in the first direction, the second gear 306 is configured to rotate in the second direction (the second direction being opposite to the first direction). The first direction and the second direction may be clockwise or anticlockwise, or vice versa. For example, upon rotation of the actuator 302 in the clockwise direction, the first gear 304 is configured to rotate in the clockwise direction, causing the second gear 306 to rotate in the anticlockwise direction.
[62] A gear ratio of the first gear 304 and the second gear 306 is designed based upon requirements. In an embodiment, the gear ratio is less than one such that the second gear 306 has a rotational speed smaller than a rotational speed of the first gear 304 and provides a greater torque than that provided by the first gear 304. The gear ratio of less than one may be achieved in a variety of ways. For example, a diameter of the second gear 306 may be larger than the first gear 304. Alternatively, or in addition, the number of second teeth 306c are more than the number of first teeth 304b. In an embodiment, the second gear 306 has a higher diameter than that of the first gear 304 and number of second teeth 306c are more than the number of first teeth 304b. The number of teeth on the second gear 306 and the first gear 304 are chosen depending on factors such as size of the stents 500, number of stents 500 to be delivered, etc.
[63] The cam 310 is configured to rotate in response to the first trigger and the second trigger. In response to the rotation of the second gear 306 in the second direction, the cam 310 is configured to rotate in the same direction as that of the second gear 306. In other words, in response to the rotation of the actuator 302 in the first direction (e.g., clockwise direction), the cam 310 is configured to rotate in the second direction (e.g., anticlockwise direction). Though the actuator 302 and the cam 310 are coupled using the gear assembly as described herein, it should be considered as exemplary. The actuator 302 and the cam 310 may be coupled using any other manner such that the cam 310 is configured to rotate in response to receipt the first trigger or the second trigger by the actuator 302.
[64] In an embodiment, the second gear 306 and the cam 310 are disposed between two base plates 300c (as shown in Fig. 3b-3c). The base plates 300c are coupled to an inner surface of the handle 300. In one embodiment, the base plates 300c and the handle 300 are separate components. The base plates 300c may be coupled to the handle 300 using techniques, such as, without limitation, screws, snap-fit connections, adhesive bonding, ultrasonic welding, or press-fitting. In another embodiment, the base plates 300c and the handle 300 form an integrated structure, i.e., they are integrally coupled. The base plates 300c may be made of material, such as, without limitation, polycarbonate, acrylonitrile butadiene styrene (ABS), fiberglass-reinforced nylon, etc.
[65] In an embodiment, the second gear 306, the cam 310 and the base plates 300c include a respective hole. A hole of the second gear 306 (not shown), a hole 30 of the base plates 300c and a hole 31 of the cam 310 are aligned parallel to a longitudinal axis of the handle 300, as shown in Fig. 3b-3d. The hole of the second gear 306, the hole 30 of the base plates 300c and the hole 31 of the cam 310 are configured to receive a pin 40. The pin 40 is configured to hold the assembly of the second gear 306 and the cam 310 in its place and allow rotation of the aforementioned components in response to the rotation of the actuator 302. The pin 40 prevents slippage of the second gear 306 and the cam 310 from the handle 300.
[66] The cam 310 includes at least one groove 310a (hereinafter, groove 310a) running through the circumference of the cam 310. In an embodiment, the cam 310 includes one groove 310a. The groove 310a may be carved on an outer surface of the cam 310, using one or more techniques, such as, without limitation milling, laser engraving, computer numerical control (CNC) machining, or abrasive water jet cutting, etc. In an exemplary embodiment, the groove 310a is carved on the outer surface of the cam 310 using CNC machining technique.
[67] The groove 310a has a predefined pattern. In an embodiment, the groove 310a is a harmonic groove having sinusoidal or wave-like profile. In other words, the groove 310a includes one or more alternating sections. In an embodiment, the groove 310a includes one or more peaks (p) and one or more troughs (t) provided alternatingly. In an embodiment depicted in Fig. 3d, the groove 310a includes three peaks (p) and three troughs (t). The number of troughs designed on the cam 310 depend upon the number of stents 500 to be delivered. For example, number of peaks (p) and troughs (t) are equal to the number of stents 500 to be delivered plus one. In an embodiment depicted in Fig. 3d, the groove 310a includes three peaks (p) and three troughs (t). For example, the groove 310a includes a first peak, a first trough, a second peak, a second trough, a third peak and a third trough. In an embodiment, the first trough (t) corresponds to an initial configuration of the device 200. The first trough (t) is followed by the first peak (p). The first peak (p) is followed by the second trough (t). The second trough (t) is followed by the second peak (p). The second peak (p) is followed by the third trough (t), and the third trough (t) is followed by the third peak (p). The peaks (p) (e.g., the first, second and third peaks) are disposed towards a distal end of the cam 310 and the troughs (t) (e.g., the first, second and third troughs) are disposed towards a proximal end of the cam 310.
[68] A distance between the first trough (t) and the first peak (p) depends upon the distance to be traversed by the first tube 350 and the needle 400 in the distal direction from the initial position, in response to the first trigger (e.g., the first rotation of the actuator 302).
[69] The distance between a peak and a following trough determines the distance traveled by the first tube 350 in the proximal direction to expose the corresponding stent 500. In an embodiment, each successive trough from the first trough is located proximal to a previous trough. For example, the second trough is proximal to the first trough by a predefined distance, the third trough is proximal to the second trough by the predefined distance and so on. The predefined distance depends upon the length of the stent 500 to be delivered. For example, the predefined distance between the first trough and the second trough depends upon the length of the first stent 500a. Similarly, the predefined distance between the second trough and the third trough depends upon the length of the second stent 500b and so on. In an embodiment depicted herein, the stents 500 have the same length and hence, the predefined distance is the same. It is possible though that the lengths of the stents 500 may be different, and the predefined distance between successive troughs is different and chosen according to the length of the corresponding stent 500.
[70] Similarly, a distance between a trough (other than the first trough) and a following peak is determined based upon the distance to be traversed by the first tube 350 to dispose the exposed stent 500 at the distal tip 400c of the needle 400. For example, the distance between the second trough and the second peak is chosen based upon the distance to be traversed by the first tube 350 to move the first stent 500a to the distal tip 400c. Similarly, the distance between the third trough and the third peak is chosen based upon the distance to be traversed by the first tube 350 to move the second stent 500b to the distal tip 400c and so forth. According to an embodiment, the peaks – i.e., the first, second and third peaks – of the groove 310a – are circumferentially aligned, i.e., they are located at the same longitudinal distance from a proximal end of the cam 310.
[71] The peaks (p) and the troughs (t) are designed in this manner to expose and deliver successive stents 500 for each successive rotation of the actuator 302, enabling the device 200 to deliver multiple stents 500.
[72] In an embodiment, the cam 310 has a generally cylindrical body. The cam 310 has a predefined length and a predefined diameter ranging between 10 mm and 20 mm, and 10 mm and 18 mm, respectively. In an embodiment, the predefined length and diameter of the cam 310 is 16 mm and 18 mm respectively. The cam 310 may be made of material such as without limitation, aluminum, stainless steel, etc. In an embodiment, the cam 310 is made of stainless steel (SS 316).
[73] The groove 310a is coupled to the follower 312, as shown in Fig. 3e. In response to the rotation of the cam 310, the follower 312 is configured to move axially. The groove 310a defines a path followed by the follower 312.
[74] In an embodiment, the follower 312 includes a bearing 312a and a body 312b. The bearing 312a is generally cylindrical in shape, though it may have any other shape such as without limitation, spherical, conical, or elliptical, etc. The bearing 312a may have a diameter ranging between 2 mm and 8 mm. In an embodiment, the diameter of the bearing 312a is 3 mm. The bearing 312a is disposed in the groove 310a and is configured to mate with the groove 310a of the cam 310. In response to the rotation of the cam 310, the bearing 312a is configured to trace (or move along) the groove 310a, for example, move through the troughs (t) and peaks (p) of the groove 310a on the cam 310. The bearing 312a converts the rotational movement of the cam 310 into an axial movement of the follower 312.
[75] In an embodiment, the body 312b has a generally inverted L-shaped body. In an embodiment, the body 312b includes a first surface A and a second surface B, as shown in Fig. 3e. The body 312b may have a predefined thickness (T) and width (W). The predefined thickness (T) and width (W) of the body 312b may range between 02 mm and 05 mm, and 10 mm and 30 mm, respectively. In an embodiment, the predefined thickness (T) and width (W) of the body 312b is 02 mm and 26 mm, respectively.
[76] A first end 312b1 of the body 312b is coupled to the bearing 312a. In one embodiment, the bearing 312a and the body 312b may be separate components. The bearing 312a may be coupled to the body 312b via a rod 312c using techniques, such as, without limitation, screws, snap-fit connections, adhesive bonding, ultrasonic welding, or press-fitting. In an example implementation, the bearing 312a, the rod 312c and the body 312b are coupled using an adhesive bonding. In an embodiment, the bearing 312a, the rod 312c and the body 312b form an integrated structure, i.e., they are integrally coupled. The bearing 312a of the follower 312 may be made of material, such without limitation, acrylonitrile butadiene styrene (ABS), polyether ether ketone (PEEK), nylon, polycarbonate, etc. The body 312b of the follower 312 may be made of the same or different material as that of the bearing 312a. In an embodiment, the bearing 312a and the body 312b of the follower 312 are made of acrylonitrile butadiene styrene (ABS).
[77] In response to the bearing 312a tracing the path of the groove 310a on the cam 310, the body 312b is configured to move axially in a proximal or distal direction. For example, in response to the bearing 312a moving from a peak (p) to a successive trough (t) of the groove 310a, the body 312b is configured to axially move in the proximal direction. Similarly, in response to the bearing 312a moving from a trough (t) to a successive peak (p) of the groove 310a, the body 312b is configured to axially move in the distal direction. The positioning of the bearing 312a at the peak (p) defines the distal-most position of the body 312b. The positioning of the bearing 312a at the third trough (t) defines the proximal-most position of the body 312b.
[78] A second end 312b2 of the body 312b is coupled to the block 318. The block 318 includes a plurality of bars, a first support plate 330 and a second support plate 332. The first support plate 330 and the second support plate 332 are coupled to the actuator 302.
[79] In an embodiment, the plurality of bars includes a pair of first bars 320. Optionally, the plurality of bars may include a pair of second bars 322 along with the pair of first bars 320. Each bar includes a proximal end and a distal end, thereby defining a length. Each bar of the first bars 320 and the second bar 322 may have the length and a thickness ranging between 10mm and 30 mm, and 01 mm and 8 mm, respectively. In an embodiment, the first bars 320 and the second bars 322 have the same length and thickness equal to 14 mm and 1.5 mm, respectively.
[80] The pair of first bars 320 are coupled to opposite surfaces (e.g., one of first surface A or the second surface B) of the body 312b towards the second end 312b2 of the body 312b. A proximal end of each first bar 320 is coupled to a respective surface of the body 312b, such that one first bar 320 is coupled to the first surface A and the other first bar 320 is coupled to the second surface B of the body 312b, thereby, defining a first gap (G1) between the pair of first bars 320, as shown in Fig. 3g.
[81] The second bars 322 are coupled to the body 312b towards second end 312b2 of the body 312b in a similar manner. For example, a proximal end of each second bar (322) is coupled to the body 312b such that one second bar 322 is coupled to the first surface A and the other second bar 322 is coupled to the second surface B of the body 312b. Thus, the second bars 322 too have the gap (G1). The dimension of the gap G1 is same as that of the width (W) of the body 312b of the follower 312, as shown in Figs. 3f-3g. Further, the second bars 322 are coupled to the body 312b at a predefined vertical distance from the first bars 320, thereby defining a predefined a second gap (G2) therebetween. The second gap (G2) between the pair of first bars 320 and the pair of second bars 322 may range between 1.0 mm and 5.0 mm. In an embodiment, the second gap (G2) is 2.0 mm.
[82] The proximal end of the first bars 320 and the second bars 322 may be coupled to the body 312b of the follower 312 using techniques, such as, without limitation, sliding fit, interlocking mechanisms etc. In an embodiment, the proximal ends of the pair of first bars 320 and the pair of second bars 322 are coupled to the body 312b of the follower 312 using sliding fit.
[83] The second end 312b2 of the body 312b of the follower 312 is coupled to the first support plate 330. The pair of first bars 320 and the pair of second bars 322 are coupled to the first support plate 330 and the second support plate 332.
[84] In an embodiment, a distal end of each of the first bars 320 and the second bars 322 are coupled to the first support plate 330 using techniques, such as, without limitation welding, bolting, riveting, press fitting, adhesive bonding, etc. In an embodiment, the distal ends of the pair of first bars 320 and the pair of second bars 322 are coupled to the first support plate 330 using integral molding technique. In another embodiment, the pair of first bars 320, the pair of second bars 322 and the first support plate 330 form an integrated structure, i.e., they are integrally coupled. The first support plate 330 may have a shape including, but not limited to, oval, elliptical, rectangle, round-rectangle etc. In an embodiment, the first support plate 330 is round-rectangle in shape. the first support plate 330 may have a length and a width ranging between 5 mm and 30mm, and 1mm and 5 mm, respectively. In an embodiment, the length and the width of the first support plate 330 is 9 mm and 1 mm, respectively.
[85] In response to the axial movement of the follower 312, the first support plate 330 is configured to move in the same direction. For example, in response to the follower 312 moving in the proximal direction, the first support plate 330 is configured to move in the proximal direction. Similarly, in response to the follower 312 moving in the distal direction, the first support plate 330 is configured to move in the distal direction.
[86] The first tube 350 is coupled to the first support plate 330. In an embodiment, the first support plate 330 includes a first hole 330a at a center, as shown in Fig. 3f. The first hole 330a is configured to receive the first tube 350 of the plurality of tubes, as shown in Fig. 3h. The first support plate 330 is seated on the groove 350d of the first tube 350. In an embodiment, the first hole 330a is configured to engage with the groove 350d of the first tube 350. The proximal end 350a of the first tube 350 may be coupled to the first hole 330a of the first support plate 330 using techniques, such as, without limitation, welding, press fitting, adhesive bonding, etc. In an embodiment, the first tube 350 is coupled to the first hole 330a of the first support plate 330 using adhesive bonding.
[87] In response to the axial movement of the first support plate 330, the first tube 350 is configured to move in the same direction. For example, in response to the movement of the first support plate 330 in the proximal direction, the first tube 350 is configured to move in the proximal direction. Similarly, in response to the movement of the first support plate 330 in the distal direction, the first tube 350 is configured to move in the distal direction.
[88] The second support plate 332 is disposed between the first support plate 330 and the body 312b of the follower 312, as shown in Fig. 3f. The second support plate 332 may have a shape including, but not limited to, oval, elliptical, rectangle, round-rectangle, etc. In an embodiment, the second support plate 332 is round-rectangle in shape. The first support plate 330 and the second support plate 332 may have the same or different dimensions. In an embodiment, the second support plate 332 has larger length than that of the first support plate 330. The second support plate 332 may have a length and a width ranging between 8 mm and 30 mm, and 1 mm and 8 mm, respectively. In an embodiment, the length and the width of the second support plate 332 is 12 mm and 2 mm, respectively.
[89] The needle 400 is coupled to the second support plate 332. The second support plate 332 includes a second hole 332a, as shown in Figs. 3f-3g. The second hole 332a is configured to receive the proximal end 400a of the needle 400, as shown in Fig. 3h. The needle 400 is fixedly coupled to the second hole 332a of the second support plate 332 using techniques, such as, without limitation welding, bolting, riveting, press fitting, adhesive bonding, etc., or a combination thereof. In an embodiment, the needle 400 is coupled to the second hole 332a by combining the press fitting and adhesive bonding.
[90] The second support plate 332 includes two wings 332b. In an embodiment, each lateral side of the second support plate 332 includes one wing 332b, as shown in Fig. 3g. The second support plate 332 is coupled to the actuator 302 via the cam assembly and the gear assembly. In the initial configuration, a proximal face of the second support plate 332 mates with a distal face of the body 312b of the follower 312 according to an embodiment, thereby coupling the second support plate 332 with the cam assembly.
[91] In an embodiment, the device 200 includes a pair of planks 300d. In an embodiment, each first bar 320 is disposed over a corresponding plank 300d of the pair of planks 300d. The pair of first bars 320 are configured to slide over the pair of planks 300d. Each second bar 322 is disposed below the corresponding plank 300d. A length of each plank 300d is same as that of the length of each bar of the pairs of first bars 320.
[92] Each plank 300d includes a slot D. The slot D extends longitudinally. The slot D of each plank 300d receives the corresponding wing 332b of the second support plate 332, as shown in Fig. 3j. The wings 332b of the second support plate 332 are configured to move within the corresponding slot D, in response to the distal motion of the second support plate 332.
[93] In an embodiment, each of the second gaps (G2) is configured to receive a plank (300d), as shown in Fig. 3i. The wings 332b are disposed between the first pair of the bars 320 and second pair of bars 322. In other words, the wings 332b are disposed within the second gap (G2). A height of each plank 300d is same as that of the height of the second gap (G2).
[94] The planks 300d are coupled to a body of the handle 300. In one embodiment, the planks 300d and the body of handle 300 are separate components coupled using techniques, such as, without limitation, press fitting, interference fitting, or adhesive bonding, etc. In another embodiment, the planks 300d and the handle 300 may form an integrated structure, i.e., they are integrally coupled. The first bars 320 and the second bars 322 are configured to slide over the planks 300d while moving in one of the proximal or distal direction. The planks 300d may be made of made of material, such as, without limitation stainless steel (SS 316), ceramic, tungsten carbide, etc.
[95] The movement of the block 318 caused by the movement of the follower 312 is explained below according to an embodiment. In response to the movement of the bearing 312a from the first trough (t) to the first peak (p), the body 312b of the follower 312 is configured to move axially in the distal direction and push the second support plate 332 in the distal direction. The second support plate 332 is movable only in the distal direction. Once the second support plate 332 moves in the distal direction, the second support plate 332 is refrained from moving in the proximal direction. The absence of direct coupling with any one of the follower 312, first bars 320 and the second bars 322 prevents proximal movement of the second support plate 332 and ensures unidirectional movement of the second support plate 332 in the distal direction. In response to the distal movement of the second support plate 332, the needle 400 is configured to move in the distal direction. Since the second support plate 332 is movable only in the distal direction, the needle 400 too is only movable in the distal direction.
[96] In response to the axial movement of the follower 312, the block 318 is configured to move axially in the same direction. For example, in response to the follower 312 moving axially in the distal direction, the block 318 moves in the distal direction. During the movement of the block 318 in the distal direction, the body 312b of the follower 312 is configured to push the first support plate 330 and the second support plate 332 in the distal direction. The body 312b of the follower 312 pushes the second support plate 332 in the distal direction.
[97] In response to the first support plate 330 and the second support plate 332 moving in the distal direction, the first tube 350 of the plurality of tubes and the needle 400 move in the distal direction, respectively. Similarly, the axial movement of the follower 312 in the proximal direction causes the first support plate 330 and the plurality of bars of the block 318 to move towards the proximal direction. As explained earlier, the second support plate 332 does not move in the proximal direction. In response to the movement of the first support plate 330 in the proximal direction, the first tube 350 is configured to move in the proximal direction. During the movement of the first tube 350 of the plurality of tubes in the proximal direction, the needle 400 remains stationary because the second support plate 332 doesn’t move proximally in response to the proximal movement of the follower 312.
[98] The second support plate 332 moves in the distal direction for a predefined length. In an embodiment, aa slab 80 is provided between the first support plate 330 and the second support plate 332, as shown in Fig. 3h. The slab 80 is configured to restrict the distal movement of the second support plate 332. In an embodiment, the second support plate 332 move in the distal direction until a distal face of the second support plate 332 contacts a proximal face of the slab 80. The predefined length is same as the distance between the distal face of the body 312b and the proximal face of the slab 80. In an embodiment, the slab 80 is equidistantly placed between the first support plate 330 and the body 312b of the follower 312, though the slab 80 may be placed at any other distance. The slab 80 is fixedly coupled to the inner surface of the handle 300. In one embodiment, the slab 80 and the handle 300 may be separate components coupled using techniques, such as, without limitation, welding, bolting, riveting, press fitting, adhesive bonding, etc. In an embodiment, the slab 80 and the handle 300 are coupled using adhesive bonding. The slab 80 remains stationary throughout the operation of the device 200. The slab 80 may be made of materials such as, without limitation, Nitinol, stainless steel (SS 316L), titanium, etc. In an embodiment, the slab 80 is made of stainless steel.
[99] The second tube 360 (i.e., the inner tube) of the plurality of tubes is fixedly coupled to the slab 80. The proximal end 360a of the second tube 360 may be coupled to the slab 80 using techniques, such as, without limitation, adhesive bonding, press-fitting, welding etc. In an embodiment, the second tube 360 is coupled to the slab 80 using adhesive bonding. The second tube 360 is fixedly coupled to the slab 80, which in turn is fixedly coupled to the handle 300, thus the second tube 360 is immovable with respect to the axial movement of the first tube 350 and the needle 400. In other words, the second tube 360 (or the inner tube) remains stationary throughout the operation of the device 200.
[100] In an embodiment, the coupling assembly includes a holder plate 345 provided distal to the first support plate 330, as shown in Figs. 4a-4c. The holder plate 345 may have a shape, including but not limited to, oval, elliptical, round-rectangle, etc. In an embodiment, the holder plate 345 has round-rectangle shape. The holder plate 345 may have a length and a width ranging between 05 mm and 15 mm, and 02 mm and 10 mm, respectively. In an embodiment, the length and the width of the holder plate 345 are 09 mm and 04 mm, respectively. The holder plate 345 may have a thickness on a lateral side that may range between 0.5 mm and 05 mm. In an embodiment, the thickness of the holder plate 345 is 02 mm. The holder plate 345 may be made of stainless steel (SS 316), aluminum, polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyethylene (PE), etc. In an embodiment, the holder plate 345 is made of acrylonitrile butadiene styrene (ABS).
[101] The holder plate 345 may be coupled to the inner surface of the handle 300 at the distal end 300b using techniques, such as, without limitation, screws, snap-fit connections, adhesive bonding, ultrasonic welding, or press-fitting. In an embodiment, a distal face of the holder plate 345 is fixedly coupled to the inner surface of the handle 300 at the distal end 300b using adhesive bonding. In other words, the holder plate 345 is immovable, i.e., remains stationary.
[102] The first support plate 330 of the block 318 is coupled to the holder plate 345. In an embodiment, a distal face of the first support plate 330 and a proximal face of the holder plate 345 are coupled via the at least one resilient member 340.
[103] In an embodiment, the coupling assembly includes two resilient members 340. Each resilient member 340 includes a proximal end 340a and a distal end 340b. The proximal end 340a of each resilient member 340 is coupled to the distal face of the first support plate 330 of the block 318. In an embodiment, the distal face of the first support plate 330 includes at least one slot 330b (as shown in Fig. 4b). The proximal end 340a of each resilient member 340 is disposed within the respective slot 330b of the first support plate 330.
[104] The distal end 340b of the resilient member 340 is coupled to the proximal face of the holder plate 345. In an embodiment, the proximal face of the holder plate 345 includes at least one slot 345b (as shown in Fig. 4c). The distal end 340b of each resilient member 340 is disposed within the respective slot 345b of the holder plate 345.
[105] The resilient members 340 are coupled to the first support member 330 and the holder plate 345 using techniques, such as, without limitation, snap-fit connections, adhesive bonding, ultrasonic welding, etc. In an embodiment, the resilient members 340 are coupled to the first support member 330 and the holder plate 345 using adhesive bonding technique. In an embodiment, the resilient members 340 are arranged parallel to each other and are aligned with the longitudinal axis of the handle 300.
[106] In an embodiment, the resilient members 340 are compression springs. In response to the movement of the block 318 in the distal direction, the resilient members 340 are configured to provide resilience to push-back the block 318 in the proximal direction, each time the block 318 is moved in the distal direction. For example, in response to the movement of the first support plate 330 in the distal direction, the resilient members 340 move to a compressed state and are configured to apply a resilient force on the first support plate 330 in a proximal direction.
[107] In an embodiment, the holder plate 345 includes a third hole 345a, as shown in Fig. 4c. The third hole 345a is configured to receive the third tube 370 (i.e., the outer tube) and the fourth tube 380 (i.e., the second intermediate tube) of the plurality of tubes.
[108] The proximal end 370a of the third tube 370 is coupled to the holder plate 345. In one embodiment, the groove 370d at the proximal end 370a of the third tube 370 is configured to receive the holder plate 345. In other words, the third hole 345a of the holder plate 345 is coupled to the groove 370d of the third tube 370. In an embodiment, the third tube 370 (or, the outer tube 370) and the holder plate 345 are coupled using technique, such as, without limitation, snap-fit connections, adhesive bonding, and ultrasonic welding. In another embodiment, the third tube 370 and the holder plate 345 are integrated structure (i.e., integrally coupled) and are snug fit into a wall of the handle 300 at the distal end 300b. In yet another embodiment, the proximal end 370a is coupled to the holder plate 345 and the groove 370d is configured to receive the distal end 300b of the handle 300. The groove 370d is coupled to the distal end 300b of the handle 300 using adhesive bonding technique, though other suitable coupling mechanisms may be used.
[109] The proximal end 380a of the fourth tube 380 is coupled to the holder plate 345. In an embodiment, the proximal end 380a of the fourth tube 380 is disposed within the third hole 345a of the holder plate 345. The proximal end 380a of the fourth tube 380 may be coupled to the third hole 345a of the holder plate 345 using techniques, such as, without limitation, welding, brazing, press fitting, or a combination thereof. In an embodiment, the fourth tube 380 is coupled to the third hole 345a of the holder plate 345 using press fit & adhesive bonding. In another embodiment, the proximal end 380a of the fourth tube 380 is coupled to the distal end 300b of the handle 300.
[110] The holder plate 345 is immovable, thus, the third tube 370 and the fourth tube 380 are immovable with respect to the movement of the first tube 350 and the needle 400. In other words, the third tube 370 (i.e., the outer tube) and the fourth tube 380 (i.e., the second intermediate tube) of the plurality of tubes remain stationary during the operation of the device 200.
[111] Fig. 6 depicts a flowchart of a method 600 of operating the device 200, according to an embodiment of the present disclosure.
[112] At step 601, the distal tip 400c of the needle 400 is inserted into an eye of the patient through the corneal layer of the eye and is positioned slightly away from the target site. The needle 400 is penetrated into the eye until the distal end 380b of the fourth tube 380 is inserted into the eye. At this point, the device is in an initial stage (or initial configuration). Arrangement of various components of the device 200 in the initial configuration are explained below. In this configuration, the one or more stents 500 are disposed on the needle 400 and are within the first intermediate tube of the plurality of tubes, for example, within the first tube 350, as shown in Fig. 7a. The distal end 360b of the second tube 360 abuts the proximal end of a proximal-most stent of the stents 500 (the second stent 500b in the depicted example). The distal-most stent of the stents 500 (the first stent 500a in the depicted example) is at the distal end 350b of the first tube 350. The follower 312 and the block 318 of the coupling assembly is disposed at a respective initial position, as shown in Fig. 7b. The bearing 312a of the follower 312 is disposed at the first trough (t) of the cam 310. The body 312b of the follower 312 is in contact with a proximal face of the second support plate 332. The proximal ends of the first bars 320 and the second bars 322 and the second end 312b2 of the body 312b of the follower 312 are aligned with a proximal end of the planks 300d.
[113] At step 602, a first trigger is provided to the device 200. According to an embodiment, to provide the first trigger, the actuator 302 is rotated in a first direction for a first time. In other words, a first rotation of the actuator 302 in the first direction is configured to generate the first trigger. In an embodiment, the first direction is a clockwise direction.
[114] In response to the first trigger (e.g., the rotation of the actuator 302), the gear assembly is activated. As explained earlier, in response to rotation of the actuator 302, the first gear 304 rotates in the clockwise direction and causes the second gear 306 to rotate in the anticlockwise direction.
[115] In response to the activation of the gear assembly, the cam assembly is activated. As explained earlier, in response to rotation of the second gear 306, the cam 310 is configured to rotate in the anticlockwise direction. Thus, in response to the first trigger, the cam 310 is configured to rotate. As the cam 310 rotates, the bearing 312a of the follower 312 traces the path provided by the groove 310a of the cam 310. In an embodiment, in response to the first trigger received by the actuator 302 (e.g., the first rotation of actuator 302), the bearing 312a moves from the first trough (t) to the first peak (p) of the groove 310a, moving the follower 312 in the distal direction, as shown Fig. 8a.
[116] In response to the activation of the cam assembly, the block 318 is configured to move in the distal direction. For example, the follower 312 is configured to push the block 318 in the distal direction. In an embodiment, the plurality of bars (e.g., the first bars 320 and the second bars 322) is configured to slide over the plank 300d of the handle 300 in the distal direction, in response to the distal movement of the body 312b of the follower 312. The body 312b of the follower 312 is configured to push the first support plate 330 to move in the distal direction for a first predefined length. The first predefined length is equal to the distance between the first trough (t) and the first peak (p) of the groove 310a on the cam 310. In response to the movement of the first support plate 330 in the distal direction, the first tube 350 is configured to move in the distal direction, as shown in Fig. 8b. Thus, on receipt of the first trigger, the first tube 350 is configured to move in the distal direction for the first predefined length.
[117] Further, the body 312b of the follower 312 pushes the second support plate 332 to move in the distal direction as explained earlier. The wings 332b of the second support plate 332 slide within the slot D of the planks 300d. The distal movement of the second support plate 332 causes the needle 400 to move in the distal direction. Thus, on receipt of the first trigger, the needle 400 is configured to move in the distal direction for the first predefined length.
[118] The second support plate 332 moves in the distal direction and abuts with the slab 80 (as shown in Fig. 8a), restricting further movement of the second support plate 332 in the distal direction, thereby, restricting further movement of the needle 400 in the distal direction by a predefined length. The predefined length corresponds to the distance traversed by the second support plate 332 from its initial position to the slab 80, i.e., the distance between the distal face of the second support plate 332 and the proximal face of the slab 80 at the initial position of the device 200.
[119] The distal movement of the first support plate 330 induces compression in the at least one resilient member 340. This biases the resilient members 340.
[120] At step 604, the first trigger is released (i.e., the actuator 302 is released) to expose a distal-most stent of the stents 500. Upon releasing the actuator 302, i.e., upon release of the first trigger, the resilient members 340 apply a biasing force on the first support plate 330, causing the first support plate 330 to move in the proximal direction. Due to the coupling of the first support plate 330 with the body 312b of the follower 312 through the plurality of bars, the movement of the first support plate 330 in the proximal direction causes the body 312b of the follower 312 to move in the proximal direction, causing the bearing 312a of the follower 312 to slide down from the first peak (p) to the second trough (t) on the cam 310. The proximal movement of the first support plate 330 continues until the proximal end of the plurality of bars and the second end 312b2 of the body 312b of the follower 312 align with the proximal end of the planks 300d, i.e., reach respective initial positions. As explained earlier, the second support plate 332 remains stationary at this stage. Thus, on the release of the first trigger, the first support plate 330 is configured to move the body 312b axially in the proximal direction and move the bearing 312a within the at least one groove 310a.
[121] Further, in response to the movement of the first support plate 330 in the proximal direction, the first tube 350 moves in the proximal direction. The distance traveled by the first support plate 330 and the first tube 350 in the proximal direction, in response to the release of the first trigger, is equal to the distance between the distance between the first peak (p) and the second trough (t) of the groove 310a on the cam 310. As the second trough is proximal to the first trough, the distance travelled by the first tube 350 in the proximal direction upon release of the first trigger is greater than the distance travelled by the first tube 350 in the distal direction upon receipt of the first trigger.
[122] Since the second trough is proximal to the first trough of the groove 310a by the distance equal to the length of the first stent 500a, the first tube 350 moves over the first stent 500a and the distal end 350b of the first tube 350 is disposed proximal to the proximal end of the first stent 500a. Thus, upon release of the first trigger, the first tube 350 is configured to retract with respect to at least a portion of the needle 400, exposing the first stent 500a of the one or more stents 500 out of the first tube 350. As explained earlier, the tapered portion 350c expands to allow the first tube 350 to move backwards over the first stent 500a.
[123] At step 606, a second trigger is provided to push (or move) the exposed stent 500 (from step 606) to move to the distal tip 400c of the needle 400. In an embodiment, to provide the second trigger, the actuator 302 is rotated in the clockwise direction for a second time. In other words, a second rotation of the actuator 302 is configured to generate the second trigger to move the exposed stent 500 to the distal tip 400c of the needle 400. In response to the second trigger provided by the actuator 302, the first gear 304, the second gear 306 and the cam 310 rotate in a similar manner as described earlier. Consequently, the bearing 312a of the follower 312 moves from the second trough (t) to the second peak (p) of the groove 310a. This causes the body 312b of the follower 312 to move in the distal direction.
[124] In response to the movement of the follower 312 in the distal direction, the plurality of bars is configured to slide over the planks 300d, as shown in Fig. 10a. The first support plate 330 is pushed in the distal direction, causing the first tube 350 to move in the distal direction in a similar manner as described earlier. It should be noted that the second support plate 332, which is abutted with the slab 80, remains stationary at this step.
[125] As the first tube 350 moves in the distal direction, the distal end 350b of the first tube 350 abuts the proximal end of the exposed stent 500 (from step 606) and pushes the exposed stent 500 (the first stent 500a in the depicted example) to the distal tip 400c of the needle 400, as shown in Fig. 10b. The tapered distal end 350b of the first tube 350 restricts the exposed stent 500 from re-entering the plurality of tubes. Thus, upon receipt of the second trigger, the first tube 350 is configured to retract with respect to at least a portion of the needle 400, the exposed first stent 500a of the one or more stents 500 is pushed to the needle tip 400c.
[126] At step 608, the first stent 500a (from step 608) is pushed manually by the user at the target site (i.e., into the corneal layer) to deploy the first stent 500a.
[127] Steps 604 to 608 may be repeated to expose, deliver and deploy remaining stents 500 (the second stent 500b in the depicted example). For example, upon release of the second trigger, the first tube 350 is configured to retract to expose a second stent 500b of the one or more stent 500 is exposed out of the first tube 350. Upon receipt of a third trigger, the first tube 350 is configured to push the exposed second stent 500b to the distal tip 400c of the needle 400. It should be understood that the method described above can be extended in a similar manner to delivery more than two stents 500.
[128] The first rotation and the second rotation may correspond to rotating the actuator 302 by a first predefined degree and a second predefined degree, respectively. The first predefined degree and the second predefined degree depends upon the gear ratio between the first gear 304 and the second gear 306, the distance desired to be traveled by the first tube 350 and the needle 400 (which in turn are dependent on factors such as the size of the stents 500, number of stents 500 to be delivered, etc.).
[129] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:We claim:
1. A device (200) comprising:
a. an actuator (302) configured to receive at least a first trigger and a second trigger;
b. a coupling assembly comprising:
I. a first support plate (330) coupled to the actuator (302);
II. a second support plate (332) coupled to the actuator (302) and configured to move in a distal direction in response to the first trigger; and
III. at least one resilient member (340) coupled to the first support plate (330) and configured to apply a resilient force to push the first support plate (330) in a proximal direction;
c. a first tube (350) coupled to the first support plate (330) and configured to cover one or more glaucoma stents (500) in an initial configuration; and
d. a needle (400) coupled to the second support plate (332) and configured to hold the one or more glaucoma stents, the needle (400) including a needle tip (400c);
wherein, on receipt of the first trigger, the first tube (350) and the needle (400) are configured to move in the distal direction;
wherein, upon release of the first trigger, the first tube (350) is configured to retract with respect to at least a portion of the needle (400), exposing a first stent (500a) of the one or more stents (500) out of the first tube (350);
wherein, on receipt of the second trigger, the first tube (350) is configured to push the exposed first stent (500a) to the needle tip (400c).
2. The device (200) as claimed in claim 1, wherein the coupling assembly comprises:
a. a cam (310) coupled to the actuator (302) and configured to rotate in response to the first trigger and the second trigger, the cam (310) comprising at least one groove (310a) provided on a circumference of the cam (310); and
b. a follower (312) comprising:
i. a bearing (312a) disposed in the at least one groove (310a) of the cam (310);
ii. a body (312b) having a first end (312b1) coupled to the bearing (312a) and a second end (312b2) coupled to the first support plate (330); and
wherein, in the initial configuration, a distal face of the body (312b) is configured to mate with a proximal face of the second support plate (332),
wherein, in response to the rotation of the cam (310), the bearing (312a) is configured to move along the at least one groove (310a) and the body (312b) is configured to move axially in the distal direction,
wherein, on the release of the first trigger, the first support plate (330) is configured to move the body (312b) axially in the proximal direction and move the bearing (312a) within the at least one groove (310a).
3. The device (200) as claimed in claim 3, the at least one groove (310a) comprises a first trough, a first peak, a second trough, and a second peak arranged alternately, wherein the first and second peaks are disposed towards a distal end of the cam (310) and the first and second troughs are disposed towards a proximal end of the cam (310), wherein the second trough is proximal to the first trough by a predefined distance;
wherein, in the initial configuration, the bearing (312a) is disposed at the first trough;
wherein, on the receipt of the first trigger, the bearing (312a) is configured to move from the first trough (t) to the first peak (p);
wherein, upon the release of the first trigger, the bearing (312a) is configured to move from the first peak (p) to the second trough (t);
wherein, on the receipt of the second trigger, the bearing (312a) is configured to move from the second trough (t) to the second peak (p).
4. The device (200) as claimed in claim 3, wherein the coupling assembly comprises:
a. a first gear (304) coupled to the actuator (302) and comprising a plurality of first teeth (304b), the first gear (304) configured to rotate in a first direction upon receiving the first trigger and the second trigger; and
b. a second gear (306) coupled to the cam (310), the second gear (306) comprising a plurality of second teeth (306c) configured to mate with the plurality of first teeth (304b), the second gear (306) configured to rotate in a second direction opposite to the first direction; and
wherein, in response to the rotation of the second gear (306), the cam (310) is configured to rotate in the second direction.
5. The device (200) as claimed in claim 3, wherein the coupling assembly comprises a pair of first bars (320), each first bar (320) having a proximal end coupled to the body (312b) of the follower (312) and a distal end coupled to the first support plate (330), wherein, the pair of first bars (320) define a first gap (G1) therebetween.
6. The device (200) as claimed in claim 6, wherein the coupling assembly comprises a pair of second bars (322), each second bar (322) having a proximal end coupled to the body (312b) of the follower (312) and a distal end coupled to the first support plate (330), wherein the pair of second bars (322) are disposed below the pair of first bars (320), defining a second gap (G2) therebetween.
7. The device (200) as claimed in claim 3, wherein the second support plate (332) is disposed between the first support plate (330) and the body (312b) of the follower (312), each lateral side of the second support plate (332) includes a wing (332b).
8. The device (200) as claimed in claim 8, the device (200) includes a pair of planks (300d), each plank (300d) includes a slot (D) configured to receive the respective wing (332b) of the second support plate (332) wherein, a pair of first bars (320) are disposed over a corresponding plank (300d) and are configured to slide over the pair of planks (300d) and a pair of second bars (322) are disposed below the pair of planks (300d).
9. The device (200) as claimed in claim 1, wherein the device (200) comprises:
a. an inner tube (360) disposed within the first tube (350) and configured to receive the needle (400), the inner tube (360) having a distal end (360b) abutting a proximal end of a proximal-most stent (500b) of the one or more glaucoma stents (500); and
b. a slab (80) disposed between the first support plate (330) and the second support plate (332), and coupled to a proximal end (360a) of the inner tube (360),
wherein, and the slab (80) is configured to restrict the distal movement of the second support plate (332).
10. The device (200) as claimed in claim 1, wherein the coupling assembly comprises:
a. a holder plate (345) provided distal to the first support plate (330)
wherein, a proximal end (340a) and a distal end (340b) of each of the least one resilient member (340) are coupled to the first support plate (330) and the holder plate (345), respectively.
11. The device (200) as claimed in claim 11, wherein the device (200) comprises:
a. an outer tube (370) disposed over the first tube (350) and having a proximal end (370a) coupled to the holder plate (345).
12. The device (200) as claimed in claim 12, wherein the device (200) comprises a fourth tube (380) disposed between the first tube (350) and the outer tube (370), and having a proximal end (380a) coupled to the holder plate (345).
13. The device (200) as claimed in claim 1, wherein the first tube (350) comprises a tapered portion (350c) provided at a distal end (350b) of the first tube (350), the tapered portion (350c) having a maximum diameter and a minimum diameter at a proximal end and a distal end, respectively, of the tapered portion (350c).
14. The device (200) as claimed in claim 1, wherein upon release of the second trigger, the first tube (350) is configured to retract to expose a second stent (500b) of the one or more stent (500) is exposed out of the first tube (350); wherein, upon receipt of a third trigger, the first tube (350) is configured to push the exposed second stent (500b) to the distal tip (400c) of the needle (400).
15. The device (200) as claimed in claim 1, wherein the actuator (302) is rotatable, wherein the first trigger comprises a first rotation of the actuator (302) in a first direction and the second trigger comprises a second rotation of the actuator (302) in the first direction.