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:
DEVICE FOR TACK DELIVERY

2. APPLICANTS:
Meril Endosurgery Pvt. Ltd., an Indian company, of the address Survey No. 135/139 Bilakhia House, Muktanand Marg, Chala, Vapi- 396191, Gujarat

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 the field of medical devices. More specifically, the present invention relates to a tacker used for mesh fixation in various medical procedures.
BACKGROUND OF INVENTION
[002] A surgical mesh is attached to soft tissues in various surgeries such as a minimally invasive surgery, an open general surgery and a laparoscopic procedure. A tack is used to secure the surgical mesh after surgery. A tack is primarily classified into a non-absorbable tack and an absorbable tack. A non-absorbable tack is a permanent metallic tack made of titanium, etc. An absorbable tack is made of a synthetic material such as polymer, etc., that is metabolized and then absorbed into the body.
[003] Generally, a manual device is used to fix the tack. The device requires significant manual force to deploy each tack, leading to surgeon fatigue, especially in long procedures. Further, given a manual force is applied for driving a tack, variation in the force applied, can result in inconsistent tack placement, increasing the risk of mesh displacement, excessive tissue trauma, or post-operative complications.
[004] While a powered tacking device has been introduced to eliminate the limitations of the manual device, such device has primarily focused on non-absorbable tack. The need for a versatile device capable of deploying both absorbable and non-absorbable tack has remained unmet in the medical field.
[005] Therefore, there is a need for a device that overcomes the above limitations of the tack fixation device.
SUMMARY OF INVENTION
[006] The present invention relates to a delivery device to deliver one or more tacks. The delivery device includes a handle, a delivery tube and an actuation assembly. The delivery tube is coupled to a distal end of the handle. The delivery tube includes an inner tube, a coiled tube, an intermediate tube and an outer tube. The inner tube has a proximal portion and a distal portion. The inner tube includes a slit extending at least partially in the distal portion of the inner tube and configured to at least partially seat a plurality of tacks. The coiled tube includes a lumen provided over the plurality of tacks at least partially seated in the slit of the inner tube. The intermediate tube is disposed over the proximal portion of the inner tube. The outer tube extends over the intermediate tube and the coiled tube. The actuation assembly is housed in the handle. The actuation assembly includes a driver coupled to the inner tube and a processing unit configured to execute instructions to switch on the driver upon receiving an actuation input. The rotation of the inner tube configures a tack of the plurality of tacks to exit the lumen of the coiled tube upon a distal movement of the plurality of tacks.
[007] 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
[008] 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.
[009] Fig. 1A depicts a perspective view of a delivery device 100, according to an embodiment of the present disclosure.
[0010] Fig. 1B depicts an exploded view of the delivery device 100A, according to an embodiment of the present disclosure.
[0011] Fig. 1C depicts an exploded view of the delivery device 100B, according to an alternative embodiment of the present disclosure.
[0012] Fig. 2A depicts an exploded view of a delivery tube 200A of the delivery device 100A, according to an embodiment of the present disclosure.
[0013] Fig. 2B depicts an exploded view of a delivery tube 200B of the delivery device 100B, according to an alternative embodiment of the present disclosure.
[0014] Fig. 3A depicts a perspective view of an inner tube 210A of the delivery tube 200A, according to an embodiment of the present disclosure.
[0015] Fig. 3B depicts a perspective view of the inner tube 210B of the delivery tube 200B, according to an alternative embodiment of the present disclosure.
[0016] Fig. 4 depicts a perspective view of a coiled tube 220 of the delivery tube 200A or 200B, according to an embodiment of the present disclosure.
[0017] Fig. 5A depicts a perspective view of an intermediate tube 230A of the delivery tube 200A, according to an embodiment of the present disclosure.
[0018] Fig. 5B depicts a perspective view of the intermediate tube 230B of the delivery tube 200B, according to an alternative embodiment of the present disclosure.
[0019] Fig. 6 depicts a perspective view of an outer tube 240 of the delivery tube 200A or 200B, according to an embodiment of the present disclosure.
[0020] Fig. 7A depicts a perspective view of a single tack 250A, in accordance with an embodiment of the present disclosure.
[0021] Fig. 7B depicts a perspective view of a plurality of tacks 250A with the inner tube 210A, in accordance with an embodiment of the present disclosure.
[0022] Fig. 8A depicts a perspective view of a single tack 250B, in accordance with an alternative embodiment of the present disclosure.
[0023] Fig. 8B depicts a perspective view of a plurality of tacks 250B with the inner tube 210B, in accordance with an alternative embodiment of the present disclosure.
[0024] Fig. 9A depicts the engagement of the tacks 250A with the coiled tube 220, in accordance with an embodiment of the present disclosure.
[0025] Fig. 9B depicts the engagement of the tacks 250B with the coiled tube 220, in accordance with an embodiment of the present disclosure.
[0026] Fig. 9A depicts a perspective view of a handle 300 of the delivery device 100, according to an embodiment of the present disclosure.
[0027] Fig. 9B depicts a perspective view of a first housing 302a of the handle 300, according to an embodiment of the present disclosure.
[0028] Fig. 10A depicts a perspective view of the assembly of the intermediate tube 230A with the coiled tube 220, in accordance with an embodiment of the present disclosure.
[0029] Fig. 10B depicts a perspective view of the assembly of the intermediate tube 230B with the coiled tube 220, in accordance with an embodiment of the present disclosure.
[0030] Fig. 11A depicts a perspective view of a handle 300 of the delivery device 100, according to an embodiment of the present disclosure.
[0031] Fig. 11B depicts a cross-sectional view of a handle 300 of the delivery device 100, according to an embodiment of the present disclosure.
[0032] Fig. 12 depicts a perspective view of an actuation assembly 400 of the delivery device 100, in accordance with an embodiment of the present disclosure.
[0033] Fig. 13A depicts a perspective view of a driver 410 of the actuation assembly 400, in accordance with an embodiment of the present disclosure.
[0034] Fig. 13B depicts a perspective view of the driver 410 with the handle 300, in accordance with an embodiment of the present disclosure.
[0035] Fig. 14A depicts a perspective view of a coupling element 420A of the actuation assembly 400, in accordance with an embodiment of the present disclosure.
[0036] Fig. 14B and Fig. 14C depict a perspective view of another coupling element 420B of the actuation assembly 400, in accordance with an alternative embodiment of the present disclosure.
[0037] Fig. 15 depicts a perspective view of an actuator 430 of the actuation assembly 400, in accordance with an embodiment of the present disclosure.
[0038] Fig. 16 depicts a perspective view of the processing unit 440 of the actuation assembly 400, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0039] 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.
[0040] 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.
[0041] 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.
[0042] 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.
[0043] Various methods described herein may be practiced by combining one or more machine-readable storage media containing the code according to the present invention with appropriate standard computer hardware to execute the code contained therein. An apparatus for practicing various embodiments of the present invention may involve one or more computers (or one or more processors within a single computer) and storage systems containing or having network access to computer program(s) coded in accordance with various methods described herein, and the method steps of the invention could be accomplished by modules, routines, subroutines, or subparts of a computer program.
[0044] The present disclosure relates to a delivery device configured for placing one or more tacks on a surgical mesh in a medical procedure such as hernia repair, laparoscopic surgery, and other mesh placement surgeries. The tack may be made from one or more absorbable polymers, such as polyglycolic acid, etc. or from one or more non-absorbable materials like titanium etc., depending on the specific requirement of the surgery.
[0045] The delivery device is designed to deploy one or more absorbable or non-absorbable tacks to achieve secure and consistent fixation of a surgical mesh. The delivery device uses a powered mechanism for the deployment of one or more tacks. The delivery device includes a handle that houses an actuation assembly at a proximal end of the delivery device. The delivery device also includes a delivery tube including a plurality of tubes that are disposed towards a distal end of the delivery device to guide the one or more tacks towards the surgical site. The actuation assembly, when actuated, advances the one or more tacks through the delivery tube, deploying it with a controlled force into a target tissue. The powered deployment of the one or more tacks minimizes tissue trauma and ensures uniform tack placement in the target tissue. Additionally, the powered mechanism enhances procedural efficiency by reducing surgeon fatigue, improving tack placement precision, and minimizing procedural duration, thereby offering improved outcomes in the surgical mesh placement procedure (hereinafter referred to as medical procedure).
[0046] Now referring to figures, Fig. 1A depicts a perspective view of the delivery device 100, according to an embodiment of the present disclosure. Figs. 1B and 1C depict an exploded view of alternate embodiments of the delivery device 100. The delivery device 100 is designed for use in various medical procedures, including but not limited to hernia repair, laparoscopic sacrocolpopexy, and other minimally invasive or open surgeries involving securing surgical mesh. In an embodiment, the present disclosure describes the delivery device 100 in the context of a hernia repair procedure. It should be understood, however, that the delivery device 100 can also be used in other types of soft tissue fixation or reinforcement surgeries. The delivery device 100 is used to deliver one or more tacks. The delivery device 100 is configured to deliver an absorbable and/or a non-absorbable tack to secure a surgical mesh to an underlying tissue.
[0047] In an embodiment, the delivery device 100 includes a proximal end 100c and a distal end 100d. The proximal end 100c of a delivery device 100 refers to the end of the delivery device 100 closest to the operator, typically remaining outside the patient's body for handling, control, or connection to other devices. The distal end 100d is the end of the delivery device 100 farthest from the operator, designed to be inserted into the patient's body to reach a target site for diagnosis or treatment.
[0048] The delivery device 100 includes a delivery tube 200 (200A or 200B), a handle 300 and an actuation assembly 400. The handle 300 is disposed at the proximal end 100c of the delivery device 100. Additionally, the delivery device 100 includes a cable 10 coupled to a proximal end of the handle 300. The cable 10 supplies power to the components of the handle 300 during the medical procedure. As depicted in Figs. 1B and 1C, the delivery device 100 includes two embodiments, i.e. delivery device 100A and delivery device 100B based on the configuration of the delivery tube 200. In the embodiment of delivery device 100A, the device includes a delivery tube 200A specifically configured for use with absorbable surgical tacks. While, the embodiment of delivery device 100B comprises a delivery tube 200B designed for deploying non-absorbable surgical tacks. The actuation assembly 400 is housed within the handle 300. The actuation assembly 400 includes various components responsible for the operation of the delivery device 100.
[0049] The delivery tube 200 is disposed at the distal end 100d of the delivery device 100. The delivery tube 200 is coupled to a distal end of the handle 300. The distal end of the delivery tube 200 is free and meant to be inserted in a patient from a surgical site. The length of the delivery tube 200 depends on the procedural requirement. The delivery tube 200 includes a plurality of tubes (shown in Fig. 2).
[0050] Fig. 2A depicts an exploded view of the delivery tube 200A of the delivery device 100, according to an embodiment of the present disclosure and Fig. 2B depicts an exploded view of the delivery tube 200B of the delivery device 100, according to an alternative embodiment of the present disclosure. The delivery tube 200A or 200B includes a proximal end 200c towards the proximal end 100c of the delivery device 100 and a distal end 200d at the distal end 100d of the delivery device 100. The proximal end 200c and the distal end 200d are used as a reference to describe the respective ends of the plurality of components of the delivery tube 200A or 200B. Each component of the delivery tube 200A or 200B has respective ends, the end towards the proximal end 200c is referred to as a proximal end of that component, similarly, the end towards the distal end 200d is referred to as a distal end of that component. In an embodiment, the delivery tube 200A or 200B includes an inner tube 210 (210A or 210B), a coiled tube 220, an intermediate tube 230 (230A or 230B), an outer tube 240 and a plurality of tacks 250 (250A or 250B). The delivery tube 200A or 200B is used to navigate the plurality of tacks 250 to the target site and help in the deployment of the plurality of tacks 250.
[0051] Fig. 3A and Fig. 3B depict a perspective view of the inner tube 210A or 210B of the delivery tube 200A or 200B respectively, according to an embodiment of the present disclosure. The inner tube 210A or 210B includes a proximal end towards the proximal end 200c of the delivery tube 200A or 200B and a distal end towards the distal end 200d. The proximal end and distal end of the inner tube 210A or 210B includes a proximal portion and a distal portion, respectively. The proximal end of the inner tube 210A or 210B is coupled to the handle 300. The inner tube 210A or 210B is configured to rotate about a longitudinal axis upon receiving an actuation and facilitate the deployment of the plurality of tacks 250 during a medical procedure. The inner tube 210A or 210B may be either solid or hollow. In an embodiment, at least a partial length at the proximal end of the inner tube 210A or 210B is solid to provide enhanced mechanical strength and rotational control over the inner tube 210A or 210B during deployment. The structure of the inner tube 210A or 210B depends on the type of tack to be deployed and coupling mechanism with the handle 300.
[0052] In an embodiment as shown in Fig. 3A, the inner tube 210A includes an elongated cylindrical structure. The inner tube 210A includes a first slot 212 at its proximal end. The proximal end of the inner tube 210A is configured to couple with the handle 300 using the first slot 212. In an embodiment, the proximal end of the inner tube 210A is at least partially disposed in the handle 300, and coupled securely to the components of the handle 300 using the first slot 212 (explained later). The first slot 212 enables secure attachment and transfers rotational motion from the actuation assembly 400 to the inner tube 210A upon receiving the actuation. In an embodiment, the inner tube 210A finds use in procedures where a straight, linear coupling between the inner tube 210A and the handle 300 is feasible, and the inner tube 210A is configured to transfer the torque directly along its central axis. For example, it may be used for delivering one or more absorbable tacks 250A.
[0053] The inner tube 210A includes a slit extending at least partially in the distal portion of the inner tube 210A. For example, the slit may extend in the entire distal portion of the inner tube 210A. In an embodiment, the slit is a full-through longitudinal slit that extends through a wall thickness of the inner tube 210A. That is, the slit extends from one end of the distal portion to the diametrically opposite end of the distal portion of the inner tube 210A. The slit is configured to at least partially seat the plurality tacks 250. Depending on the type of tack used, the slit may vary in structure. The slit of the inner tube 210A results in two arms 214a, 214b, separated by a longitudinal channel 214 in the distal portion of the inner tube 210A. The longitudinal channel 214 enables at least a portion of the tacks 250 to be seated in the space of the longitudinal channel 214. In other words, the longitudinal channel 214 included in the distal portion of the inner tube 210 that forms two opposing arms 214a, 214b, the longitudinal channel 214 and is configured to seat at least partially the plurality of tacks 250A.
[0054] In another embodiment, as shown in Fig. 3B, the proximal end of the inner tube 210B includes a bent or tilted anchor 210c at a predefined angle with respect to the elongated cylindrical structure of the inner tube 210B. The angled configuration of the anchor 210c of the inner tube 210B is configured to couple the inner tube 210B with the handle 300. The angled configuration allows the inner tube 210B to maintain effective coupling with the handle 300 and torque transmission to the coiled tube 220 during rotational movement of the inner tube 210B. The predefined angle of anchor 210c may range from 70 to 110. In an embodiment, the predefined angle is 90.
[0055] The inner tube 210B includes a slit extending at least partially in the distal portion of the inner tube 210B. For example, the slit may form a longitudinal cut along the outer surface of the inner tube 210B, creating a cavity 214c closed from three sides. The cavity 214c of the slit is dimensioned to securely hold one or more tacks 250 such as non-absorbable tacks, offering added positional stability prior to deployment. In other words, the cavity 214c is disposed at the distal portion of the inner tube 210 and configured to hold the plurality of tacks 250B.
[0056] The slit, whether full-through or partial, is oriented along the longitudinal axis of the inner tube 210 (210A or 210B) and is configured to facilitate rotational advancement of the tacks 250 in the distal portion of the inner tube 210, resulting in smooth release of the one or more tacks from the inner tube 210.
[0057] The diameter and the length of the inner tube 210 may be chosen based on procedural requirements. In an embodiment, the diameter of the inner tube 210 may range between 2.50 mm and 4.00 mm. The length of the inner tube 210 may range between 150 mm and 310 mm. In an embodiment, the length and the diameter of the inner tube 210 are 425 mm and 4 mm, respectively. The inner tube 210 may be made of a biocompatible material including, but not limited to, stainless steel, titanium alloy, etc. In an embodiment, the inner tube 210 is made of stainless steel.
[0058] Fig. 4 depicts a perspective view of the coiled tube 220 of the delivery tube 200, according to an embodiment of the present disclosure. The coiled tube 220 includes a proximal end towards the proximal end 200c of the delivery tube 200 and a distal end towards the distal end 200d of the delivery tube 200. In an embodiment, the proximal end of the coiled tube 220 is fixedly coupled to the distal end of the intermediate tube 230. The coiled tube 220 is coupled to the intermediate tube 230 using laser welding, crimping, etc. In an embodiment, the coiled tube 220 is coupled to the intermediate tube 230 using laser welding. In another embodiment, the coiled tube 220 is fixedly coupled to an inner surface of the distal portion of the outer tube 240 and configured to remain stationary during rotation of the inner tube 210. The coiled tube 220 may be a helical spring, a torsion spring, a compression spring, a coil, etc. The coiled tube 220 may be made from a material such as stainless steel, titanium alloy, etc. In an embodiment, the coiled tube 220 is made up of stainless steel (SS 304).
[0059] The coiled tube 220 includes a lumen provided over a plurality of tacks 250 at least partially seated in the slit of the inner tube 210. The coiled tube 220 includes a plurality of coils 222 extending between its proximal end and distal end, defining a helical path between two adjacent coils 222. The surface of the each coil 222 of the coiled tube 220, which comes into contact with the one or more tacks 250 (250A or 250B), is configured to guide one or more tacks 250 (250A or 250B) along the defined helical path during deployment. In other words, the surface of each coil 222 configured to assist distal movement of a wing 252b of the tack 250 along the helical path during deployment.
[0060] The plurality of tacks 250 are stacked upon each other and seated at least partially in the slit of the inner tube 210. During deployment, the inner tube 210 is rotated about its longitudinal axis. As the inner tube 210 rotates, the tacks 250 rotate in unison within the coiled tube 220. The rotational motion causes the spiral member 254 or the coiled member 258 of the tacks 250 to progressively advance to the distal end of the inner tube till the release of a tack into the target tissue. The coiled tube 220 thus provides a controlled path for the distal movement and deployment of each tack 250. The rotation of the inner tube 210 configures a tack 250 of the plurality of tacks 250 to exit the lumen of the coiled tube 220 upon a distal movement of the plurality of tacks 250.
[0061] Fig. 5A depicts a perspective view of the intermediate tube 230 of the delivery tube 200, according to an embodiment of the present disclosure. The intermediate tube 230 includes a proximal end towards the proximal end 200c of the delivery tube 200, similarly a distal end towards the distal end 200d of the delivery tube 200. The intermediate tube 230 is disposed over the proximal portion of the inner tube 210. The intermediate tube 230 includes an elongated, tubular structure with a lumen. In an embodiment, the lumen of the intermediate tube 230 is configured to accommodate the proximal portion of the inner tube 210 coaxially.
[0062] In an embodiment, the proximal end of the intermediate tube 230A includes a plurality of second slots 232 to be coupled to the handle 300. In an embodiment, at least a proximal portion of the intermediate tube 230A is disposed in the handle 300. The disposed proximal portion is fixedly coupled to the handle 300 using the plurality of second slots 232. The second slots 232 are coupled to the handle 300 using a coupling technique including, but not limited to, welding, snap-fit, locking mechanism, etc. The intermediate tube 230A remains stationary with the handle 300 during the operation of the delivery device 100.
[0063] In another embodiment depicted in Fig. 5B, the intermediate tube 230B includes an elongated cylindrical structure. As depicted in Fig. 7B, the intermediate tube 230B is disposed over the proximal portion of the inner tube 210 and is fixedly coupled to the outer tube 240. The intermediate tube 230B is configured to maintain a predefined diameter difference between the outer tube 240 and the coiled tube 220, ensuring proper alignment and mechanical stability between the outer tube 240 and the inner tube 210.
[0064] The diameter of the intermediate tube 230 is more than the diameter of the inner tube 210. The diameter and the length of the intermediate tube 230 may be chosen based on procedural requirements. The outer diameter of the intermediate tube 230 may range between 5.00 mm and 5.80 mm. The length of the intermediate tube 230 may range between 150.00 mm and 310 mm. In an embodiment, the length and the outer diameter of the intermediate tube 230 are 255.00 mm and 5.20 mm, respectively. The intermediate tube 230 may be made of a biocompatible material, including, but not limited to, stainless steel, titanium alloy, etc. In an embodiment, the intermediate tube 230 is made of stainless steel (SS 304).
[0065] Fig. 6 depicts a perspective view of the outer tube 240 of the delivery tube 200, according to an embodiment of the present disclosure. The outer tube 240 includes a proximal end at the proximal end 200c of the delivery tube 200 and a distal end at the distal end 200d of the delivery tube 200. The outer tube 240 has an elongated, tubular structure and includes at least one lumen. The lumen of the outer tube 240 is configured to accommodate the intermediate tube 230 and the inner tube 210. The outer tube 240 extends over both the intermediate tube 230 and the coiled tube 220, providing an external protective layer for the internal components. During operation of the delivery device 100, the outer tube 240 remains in a stationary position relative to the rotational movement of the inner tube 210.
[0066] In an embodiment, the proximal end of the outer tube 240 includes a plurality of third slots 242. These third slots 242 facilitate the coupling of the outer tube 240 with the handle 300 by providing an interface for engagement with corresponding features of the handle. In an embodiment, the third slots 242 of the outer tube 240 align with the second slots 232 of the intermediate tube 230. The proximal end of the outer tube 240 is coupled to the handle 300 using a coupling technique including, but not limited to, welding, snap-fit engagement, locking mechanisms, adhesive bonding, or the like. In an embodiment, at least a portion of the proximal end of the outer tube 240 is disposed within the handle 300 and is securely fixed using the aforementioned coupling techniques.
[0067] The diameter and the length of the outer tube 240 may be chosen based on procedural requirements. The outer diameter of the outer tube 240 may range between 5.00 mm and 6.00 mm. The length of the outer tube 240 may range between 400.00 mm and 430.00 mm. In an exemplary embodiment, the length and the outer diameter of the outer tube 240 are 415.00 mm and 5.80 mm, respectively. The outer tube 240 may be made of a biocompatible material, including, but not limited to, stainless steel, titanium alloy, medical-grade polycarbonate/composite, etc. In an embodiment, the outer tube 240 is made of stainless steel (SS 304).
[0068] Fig. 7A depicts a perspective view of a single tack 250A seated on the inner tube 210A, in accordance with an embodiment of the present disclosure. A tack 250A of the plurality of tacks 250A is configured to fasten tissues, sutures, or medical devices during a medical procedure. In the depicted embodiment, the tacks 250A are stacked one on top of the other and accommodated at least partially within the longitudinal channel 214 of the inner tube 210A. In an embodiment, each tack 250A is introduced into the longitudinal channel 214 individually to stack one on top of the other.
[0069] Each tack 250A includes a base member 252, a spiral member 254, and a piercing tip 256, as shown in Fig. 7A. The base member 252 extends from a proximal end to a distal end of the tacks 250A. The base member 252 tapers from the proximal end to the distal end of the tack 250A. In an embodiment, the base member 252 is cylindrical shaped, though other shapes such as rectangular, square, hexagonal, or polygonal may be used. The base member 252 includes a base cavity 252a on its top surface, configured to interface with the piercing tip 256 of an adjacent tack 250 once the tacks 250 are stacked on each other.
[0070] The base member 252 of the tack 250 includes a plurality of wings 252b – a lower wing and an upper wing 252b extending laterally outwards from a proximal portion of the base member 252. As shown in Fig. 7A, the wings 252b are disposed on opposite sides of the proximal portion of the base member 252. Specifically, the wings 252b are disposed on diametrically opposite top and bottom portions respectively, of the base member 252. Each of the wing 252b extends outwards beyond the longitudinal channel 214 provided with the inner tube 210A as depicted in Fig 7B.
[0071] In an embodiment, each wing is curved to engage with the coils 222 of the coiled tube 220. The wings 252b are configured to be guided along the surface of the coils 222 of the coiled tube 220. The coils define a helical path that directs the longitudinal movement of the tack 250 during deployment. This bilateral arrangement of the wings 252b enables stable engagement of the tacks 250A with the coils of the coiled tube 220, thereby preventing rotational slippage and ensuring accurate alignment of the tacks 250A during advancement. The wings 252b may have a flattened, flange-like shape, although other geometries, such as arcuate or trapezoidal forms, may also be used, depending on the design of the coiled tube 220. The size and orientation of the wings 252b are designed to allow secure nesting between the coils while maintaining a clearance for axial movement during deployment.
[0072] The spiral member 254 extends over at least a portion of the base member 252, say from the lower wing to the piercing tip 256. The spiral member 254 is configured to anchor the tack 250 inside a tissue. The spiral member 254 includes a plurality of spirals. In an embodiment, the spiral member 254 includes a uniform diameter and spacing, though the size and spacing may vary gradually along the longitudinal axis to modulate penetration depth and holding strength. In one embodiment, the cross-section of the spiral member 254 is semi-cylindrical, which provides a balance between flexibility and penetration stability.
[0073] The piercing tip 256 may include a conventional sharp piercing pointed configuration sufficient to effectively penetrate into a tissue. In an embodiment, the piercing tip 256 may have a blunt configuration effective to pierce tissue. The piercing tip 256 may be aligned parallel to the longitudinal axis of the spiral member 254, or be pointed obliquely off the axis of the spiral to facilitate penetration of tissue.
[0074] Fig. 8A depicts a perspective view of a single tack 250B, in accordance with an alternative embodiment of the present disclosure. In an alternative embodiment, the tack 250B includes a coiled member 258 extending from a first end 258a to a second end 258b. The coiled member 258 defines a series of spirals along its longitudinal axis. In an embodiment, the spirals are of uniform size, although the size of the spirals may vary, if desired, along the longitudinal length of the spiral. The gaps between adjacent spirals of the coiled member 258 may be either even or uneven along the longitudinal axis.
[0075] As shown in Fig. 8B, one or more tacks 250B are mounted over the distal portion of the inner tube 210B, in accordance with an embodiment of the present disclosure. In one embodiment, each tack 250B is introduced between the inner tube 210B and the coiled tube 220 individually to stack one on top of another. In this embodiment, the first end 258a of the coiled member 258 is configured to be seated in the cavity 214c formed within the slit provided in the distal portion of the inner tube 210B. The cavity 214c is dimensioned to securely receive and support the first end 258a of the tack 250B, thereby providing a stable anchoring point for the coiled member 258 relative to the inner tube 210B.
[0076] The helical body of the coiled member 258 wraps around the outer surface of the inner tube 210B, following a spiralling path along its longitudinal axis. The second end 258b of the coiled member 258 remains disposed outside the cavity 214c of the slit. The second end 258b is configured to engage with the tissue upon release of the tack 250B from the inner tube 210B. This configuration ensures that upon rotational actuation of the inner tube 210B, the coiled member 258 rotates in synchrony, causing the second end 258b of the tack 250B and the adjoining spirals to advance towards the distal end of the outer shaft. Upon release form the distal end, a tack is anchored within the target tissue. The inner tube 210B acts as a support and a driving mechanism for the one or more tacks 250B. The rotation of the inner tube 210B moves the one or more tacks in a distal direction, ensuring precise deployment of the one or more tacks 250B in soft or dense tissues. Further, this allows the one or more tacks 250B to maintain axial alignment with the inner tube 210B during storage, navigation, and actuation, minimizing the risk of tack misalignment or premature deployment.
[0077] The diameter of the spirals of the coiled member 258 is selected based on the tissue type and desired fixation strength. In an embodiment, the diameter of the tacks 250B ranges from about 3.00 mm to about 5.00 mm. A larger diameter may be used for anchoring in soft tissues, while a smaller diameter may be preferred for dense or shallow tissues to minimize over-penetration. The length of the coiled member 258 corresponds to the depth of the tissue; a longer spiral is suited for deeper tissues, whereas a shorter spiral is used for surface-level fixation. coiled member 258
[0078] The number of spirals of the coiled member 258 may be based on the required holding power and tissue consistency. In an embodiment, the number of spirals is greater than one-half turn. Each of these parameters, such as spiral diameter, spiral length, number of coils, and pitch, is independently selected and designed based on the anatomical site, tissue density, and fixation requirements.
[0079] The tacks 250 of the present invention may be manufactured from absorbable or non-absorbable materials. In one embodiment, the tacks 250A is made from absorbable materials such as polylactic-co-glycolic acid (PLGA), polyglycolic acid (PGA), etc., which are metabolized and absorbed by the body over time. In another embodiment, the tacks 250B is made from non-absorbable materials such as titanium alloy (Ti6AL4VELI), polyether ether ketone (PEEK), etc., which remain in the body to provide long-term fixation. The material selected must exhibit sufficient stiffness and strength to ensure the tack penetrates the tissue effectively without deformation during deployment.
[0080] Fig. 9A depicts the arrangement of the tacks 250A in the delivery tube, in accordance with an embodiment of the present disclosure. In this embodiment, a plurality of tacks 250A is seated within the longitudinal channel 214 of the inner tube 210A. The coiled tube 220 is helically disposed over the distal portion of the inner tube 210A. The wings 252b of each tack 250A are movably coupled to the surface of one or more coils 222 of the coiled tube 220. This engagement with the surface of the coils 222 restricts axial displacement of the tacks before deployment and provides a continuous helical path that guides the axial and rotational movement of the tacks 250A during deployment. As the inner tube 210A rotates, the engaged wings 252b follow the helical path, resulting in a controlled motion that advances a tack 250A into the target tissue.
[0081] Fig. 9B depicts the arrangement of the tacks 250B in the delivery tube, in accordance with an embodiment of the present disclosure. In this configuration, the inner tube 210B includes the cavity 214c for individually mounting the tacks 250B. The coiled tube 220 surrounds the inner tube 210B and is aligned to interface with each tack 250B. The coils 222 of the coiled tube 220 are spaced to receive and laterally support the outer edges of the coiled member 258 of each tack. This arrangement ensures that each tack 250B remains securely aligned along the longitudinal axis of the delivery system until rotational deployment is initiated. Upon rotation of the inner tube 210B, the coiled member 258 of the tack 250B follows the helical surface of the coils 222 of the coiled tube 220, allowing the tack 250 to screw into the tissue in a stable and guided manner.
[0082] Fig. 10A depicts a perspective view of the assembly of the intermediate tube 230A with the coiled tube 220, in accordance with an embodiment of the present disclosure. The distal end of the intermediate tube 230A is coupled to the proximal end of the coiled tube 220 using a coupling technique including, but not limited to, welding, snap-fit, locking mechanism, etc. In an embodiment, the intermediate tube 230A is coupled to the coiled tube 220 using welding. The coupling between the intermediate tube 230A and the coiled tube 220 is configured to hold the coiled tube 220 in a stationary position relative to the rotating inner tube 210. The stationary arrangement ensures that the coiled tube 220 provides a stable guiding path for the plurality of tacks during delivery while allowing the inner tube 210 to rotate freely within it. Additionally, the intermediate tube 230A is configured to maintain a predefined diameter difference between the outer tube 240 and the coiled tube 220, thereby preserving the structural integrity of the overall assembly and ensuring smooth operation during the rotational deployment of the tacks 250.
[0083] Fig. 10B depicts a perspective view of the assembly of the intermediate tube 230B with the coiled tube 220, in accordance with another embodiment of the present disclosure. In this embodiment, the intermediate tube 230B is not coupled to the coiled tube 220. The coiled tube 220 remains independently positioned and fixedly coupled to the outer tube 240, while the intermediate tube 230B primarily serves to align and support the outer tube 240 to the inner tube 210.
[0084] Fig. 11A depicts a perspective view, and Fig. 11B depicts a cross-sectional view of a handle 300 of the delivery device 100, according to an embodiment of the present disclosure. The handle 300 houses an actuation assembly 400 at the proximal end 100c for the delivery device 100. The handle 300 includes an ergonomic shape, which enables a medical practitioner to grip and operate the delivery device 100 comfortably. The handle 300 includes a proximal end 300a and a distal end 300b. In an embodiment, the handle 300 includes a cable port 300c and a delivery tube port 300d. The cable port 300c includes a tubular structure and is configured to receive the cable 10. The delivery tube port 300d is configured to receive and couple with the proximal end 200c of the delivery tube 200A or 200B. The diameter of the delivery tube port 300d corresponds to the outer diameter of the proximal end 200c of the delivery tube 200A or 200B.
[0085] In an embodiment, the proximal end of the inner tube 210, the intermediate tube 230, and the outer tube 240 of the delivery tube 200A or 200B may be coupled with the delivery tube port 300d using a coupling technique, such as, without limitation, welding, snap-fit, locking mechanism, etc. In another example implementation, the proximal ends of the inner tube 210, the intermediate tube 230, and the outer tube 240 are at least partially disposed within the handle 300. The proximal ends of the outer tube 240, the intermediate tube 230 and the inner tube 210 of the delivery tube 200A or 200B enter the handle 300 from the delivery tube port 300d.
[0086] The handle 300 includes a first housing 302a and a second housing 302b. The first housing 302a and the second housing 302b are coupled to form a housing 302 of the handle 300. The first housing 302a and the second housing 302b may be fixedly or removably coupled to form the housing 302. The first and second housings 302a, 302b may be coupled using a coupling method including, but not limited to welding, snap-fit, locking mechanism, etc. In an embodiment, the first and second housings 302a, 302b are coupled using a snap fit mechanism. The housing 302 of the handle 300 is configured to accommodate one or more components of the actuation assembly 400. The second housing 302b may be a mirror image of the first housing 302a. Therefore, the structure of the handle 300 is described with reference to the first housing 302a. The structure and function of the second housing 302b can be referred to from that of the first housing 302a, as shown in Fig. 11B.
[0087] The handle 300 includes a first portion 302c at the proximal end 300a and a second portion 302d at the distal end 300b of the handle 300. In an embodiment, the handle 300 includes an aperture 304, a plurality of chambers 306 and a plurality of fangs 308. The aperture 304 is disposed towards the second portion 302d of the handle 300. The aperture 304 is used to couple the handle 300 with the actuation assembly 400, as explained later in detail. The plurality of chambers 306 is provided to house various components of the actuation assembly 400. The plurality of chambers 306 are disposed in the first portion 302c to support the actuation assembly 400. The plurality of chambers 306 disposed in the second portion 302d support at least a partial portion of the plurality of tubes of the delivery tube 200. At least one chamber 306 of the handle 300 includes a display opening 306a for visualizing the number of tacks 250 deployed and/or remaining in the inner tube 210 of the delivery tube 200A or 200B. In other words, the display opening 306a is configured to indicate the number of tacks 250 remaining to be deployed.
[0088] The plurality of fangs 308 separate the chambers 306 and support components of the actuation assembly 400 and the delivery tube 200. The plurality of fangs 308 disposed towards the second portion 302d supports the outer tube 240 and the intermediate tube 230 of the delivery tube 200. In an embodiment, the plurality of third slots 242 of the outer tube 240 and the plurality of second slots 232 of the intermediate tube 230 are fixedly coupled to the plurality of fangs 308 at the second portion 302d of the handle 300. In other words, the third slot 242 of the outer tube 240 is configured to engage with a plurality of fangs 308 disposed within the handle 300 for fixed coupling. The chamber 306 includes a rectangular shape, though each chamber 306 may have a different shape depending upon the strength required.
[0089] Fig. 12 depicts a perspective view of the actuation assembly 400 of the handle 300, in accordance with an embodiment of the present disclosure. The actuation assembly 400 is configured to provide a rotational motion to the inner tube 210 of the delivery tube 200 for deployment of the tacks 250. The actuation assembly 400 includes a proximal end 400a and a distal end 400b. The proximal end 400a and the distal end 400b are used as a reference to describe the respective ends of the plurality of components of the actuation assembly 400. Each component of the actuation assembly 400 has respective ends, the end towards the proximal end 400a is referred to as a proximal end of that component, similarly, the end towards the distal end 400b is referred to as a distal end of that component. In an embodiment, the actuation assembly 400 includes a driver 410, a coupling element 420, an actuator 430 and a processing unit 440.
[0090] Fig. 13A depicts a perspective view of the driver 410 of the actuation assembly 400 and Fig. 13B depicts a perspective view of the driver 410 disposed within handle 300, in accordance with an embodiment of the present disclosure. In an embodiment, the driver 410 is positioned within the handle 300 and extends between a proximal end located at the proximal end 400a of the actuation assembly 400 and a distal end located at the distal end 400b of the actuation assembly 400. The driver 410 may be an electric motor, such as an AC motor, DC motor, or other suitable rotational drive device. In an embodiment, the driver 410 is electrically coupled to the processing unit 440 at its proximal end. Upon receiving an actuation input via the actuator 430, the processing unit 440 activates the driver 410, causing it to rotate.
[0091] In an embodiment, the driver 410 includes a rotating rod 412 at the distal end of the driver 410. The driver 410 is configured to transmit torque to the inner tube 210 via the coupling element 420. The rotating rod 412 of the driver 410 is coupled to the inner tube 210 of the delivery tube 200. Upon activation, the driver 410 imparts rotational motion to the rotating rod 412, which, in turn, causes the inner tube 210 to rotate for deploying the tacks. The driver 410 may include, but not be limited to, motor, AC/DC motor, rotating mechanism, electromagnetic spiral actuator, brushless DC motor (BLDC), etc. In an embodiment, the driver 410 is DC motor with gear box to optimize torque and rotational speed for surgical deployment requirements. Optionally and additionally, the driver 410 is coupled to the handle 300 using a clamp 414 and a plurality of fasteners 416. The clamp 414 is used to fix the position of driver 410 within the handle 300 and restricts the rotation of the driver 410 to that of the rotation of the rotating rod 412. The clamp 414 and the fastener 416 may have a conventional sharp configuration sufficient to effectively secure the driver 410 within the handle 300.
[0092] Optionally and additionally, the actuation assembly 400 may include a coupling element 420 to couple the driver 410 and the inner tube 210 of the delivery tube 200. Fig. 14A depicts a perspective view of the coupling element 420A of the actuation assembly 400, in accordance with an embodiment of the present disclosure. The coupling element 420 is disposed within the handle 300. The coupling element 420 includes a first end 420c towards the proximal end 400a of the actuation assembly 400 and a second end 420d towards the distal end 400b. The coupling element 420 includes a cylindrical shape, though the coupling element 420 may have any other shape, such as, without limitation, cube, cuboidal, polygonal prism, etc.
[0093] In an embodiment, the first end 420c of the coupling element 420 is coupled to the rotating rod 412 of the driver 410 and is configured to rotate with the rotating rod 412. The coupling element 420 may be coupled to the rotating rod 412 using any suitable coupling, including, but not limited to, adhesive bonding, snap-fit, locking mechanism, UV bonding, etc. In an embodiment, the coupling element 420 and rotating rod 412 are coupled using a connector, D-shaft interface, set-screw lock, etc. The second end 420d of the coupling element 420 is coupled to the inner tube 210 of the delivery tube 200. The coupling element 420 may be coupled to the inner tube 210 using any suitable coupling, including, but not limited to, adhesive bonding, snap-fit, locking mechanism, UV bonding, etc.
[0094] The coupling element 420 includes two embodiments based on the inner tube 210. The coupling element 420A corresponds to the inner tube 210A, while the coupling element 420B is for the inner tube 210B. In an embodiment, the coupling element 420A includes a first lumen 420e, a first hole 420f and a pin 422. The first lumen 420e extends longitudinally through the coupling element 420A. The first lumen 420e is configured to receive the rotating rod 412 of the driver 410 and the proximal end of the inner tube 210A of the delivery tube 200A.
[0095] In an embodiment, the first slot 212 of the inner tube 210A is configured to couple with the coupling element 420A of the actuation assembly 400 via the pin 422. The first hole 420f is configured to receive at least a portion of the pin 422. The pin 422 is inserted into the first hole 420f and the first slot 212 to couple the control element 420A with the inner tube 210A. The first hole 420f and the pin 422 may be smooth, partially threaded, or fully threaded. In an embodiment, the first hole 420f and the pin 422 are smooth. The pin 422 may have a solid or hollow core. The pin 422 includes a cylindrical shape, though the pin 422 may have any other shape, such as, without limitation, cuboidal, etc.
[0096] Fig. 14B and Fig. 14C depict a perspective view of the coupling element 420B of the actuation assembly 400, in accordance with an alternative embodiment of the present disclosure. In an embodiment, the coupling element 420B includes a second lumen 424, a coupling groove 426 and a second hole 428. The second lumen 424 is disposed at a first end 420c and extends towards the second end 420d for at least a partial length of the coupling element 420B. The second lumen 424 is configured to receive and couple with the rotating rod 412 of the driver 410. The second lumen 424 of the coupling element 420B may be coupled to the rotating rod 412 using any suitable coupling, including, but not limited to, press fit, adhesive bonding, snap-fit, locking mechanism, UV bonding, etc. In an embodiment, the coupling element 420B and the rotating rod 412 are coupled using press fit.
[0097] The coupling groove 426 is disposed at a second end 420d and extends towards the first end 420c for at least a partial length of the coupling element 420B. in other words, the coupling groove 426 to couple the anchor 210c of an inner tube 210B. The second hole 428 is disposed on the outer surface of the coupling element 420B and extends towards an interior core of the coupling element 420B. The second hole 428 fuses with the coupling groove 426 at the interior core, forming a second cavity. The second cavity of the coupling element 420B is configured to couple the angled configuration of the anchor 210c of the inner tube 210B. In other words, the anchor 210c is configured to couple with a coupling element 420B in an angled configuration. The anchor 210c passes through the coupling groove 426 and sits within the second hole 428, preventing the inner tube 210B from sliding out of the coupling assembly 420B. The shape and dimensions of the second cavity correspond to the shape and dimensions of the anchor 210c. The coupling groove 426 of the coupling element 420B may be coupled to the anchor 210c of the inner tube 210B using any suitable coupling, including, but not limited to, adhesive bonding, snap-fit, locking mechanism, UV bonding, etc. In an embodiment, the coupling element 420B and the inner tube 210B are coupled using a hollow tube or with a solid pin.
[0098] While the depicted embodiments illustrate the coupling elements 420, a person skilled in the art will appreciate that numerous variations can be implemented while maintaining the coupling and rotational functionality of the driver 410 and the inner tube 210. These variations are within the scope of the teachings of the present disclosure.
[0099] The actuator 430 is configured to receive an actuation input, i.e. the actuator 430 is configured to turn on or turn off the delivery device 100. The actuator 430 may include, but not limited to, a push button, a rotatory knob, operating switch, etc. Fig. 16 depicts a perspective view of the actuator 430 of the actuation assembly 400, in accordance with an embodiment of the present disclosure. The actuator 430 is configured to operate via a pushing or pressing action and activates rotation of the rotating rod 412 of the driver 410 about a longitudinal axis. The actuator 430 imparts activation of the processing unit 440 and results in rotational motion to the driver 410.
[00100] In an embodiment, the actuator 430 includes a plunger 432, a mounting part 434, a panel 436, and a plurality of connecting wires 438. The plunger 432 is positioned at least partially out of the aperture 304 of the handle 300, enabling easy handling and accessibility for a medical practitioner. The plunger 432 relies on the external force to turn on or turn off the delivery device 100. In an embodiment, the plunger 432 is pressed to turn on the delivery device 100 and released to turn off the delivery device 100, i.e. the plunger 432 that closes an electrical circuit upon actuation and activates the processing unit 440. In another embodiment, the plunger 432 is a knob which can be rotated to tun on or turn off the delivery device 100. The plunger 432 may be generally circular. Optionally and additionally, a cap may be used to cover the plunger 432, thereby protecting the internal mechanism of the actuator 430.
[00101] The mounting part 434 extends from the plunger 432 such that the mounting part 434 is disposed in the handle 300. The mounting part 434 is coupled to the panel 436. The mounting part 434 is coupled with the plunger 432 and the panel 436 using any suitable coupling, including, but not limited to, adhesive bonding, snap-fit, locking mechanism, UV bonding, etc. The mounting part 434 is configured to secure the plunger 432 to the panel 436. The panel 436 is disposed in the handle 300 and fixedly coupled to the fangs 308 of the handle 300. The panel 436 is configured to open and close the electric circuit while receiving the actuation input from the plunger 432. The plurality of connecting wires 438 are disposed within the handle 300. The plurality of connecting wires 438 couple the panel 436 to the processing unit 440. In an embodiment, when the plunger 432 is pressed, it turns on the processing unit 440, and when the plunger 432 is released, the processing unit 440 is turned off.
[00102] It should be noted that although the plunger 432, the mounting part 434, the panel 436, and the plurality of connecting wires 438 are described herein, it is possible that other conventional known switch, button or knob can be used in the present disclosure.
[00103] Fig. 16 depicts a perspective view of the processing unit 440 of the actuation assembly 400, in accordance with an embodiment of the present disclosure. The processing unit 440 is operably connected to the driver 410 and is configured to execute instructions to switch on the driver 410 upon receiving an actuation input. The processing unit 440 regulates the rotational speed, expressed in revolutions per minute (RPM), of the driver 410 based on the input command and the type of tacks 250 intended for deployment. The RPM of the driver 410 is controlled within a defined range depending on the physical characteristics and material composition of the tacks 250. In an embodiment, the absorbable tacks 250 is deployed at a driver RPM ranging from 5 to 8, while the non-absorbable tacks 250 is deployed at a driver RPM ranging from 3 to 7. These values may be varied or optimized according to the tack specifications and procedural requirements.
[00104] The processing unit 440 further comprises a display 442 configured to present information related to the deployment process. The display 442 is adapted to count and visually indicate the number of tacks 250 housed within the inner tube 210 and/or the number of tacks 250 remaining or deployed during the procedure. This enables the operator to monitor tack usage in real-time, thereby enhancing procedural control and precision. The display 442 may include LED, a counter device, etc. The driver 410 is actuated by the processing unit 440 through execution of stored instruction sets, which may be pre-programmed or dynamically updated. In various embodiments, the processing unit 440 may include, but is not limited to, a printed circuit board (PCB), microcontroller, microprocessor, personal computer, graphical processing unit (GPU), application-specific integrated circuit (ASIC), server, or any computing device capable of interpreting and executing machine-readable instructions.
[00105] An embodiment of the assembly of delivery device 100A is described below. The proximal ends of the inner tube 210A, the intermediate tube 230A, and the outer tube 240 are inserted into the delivery tube port 300d of the handle 300. The third slots 242 of the outer tube 240 and the second slots 232 of the intermediate tube 230A are fixedly engaged with the plurality of fangs 308 located in the second portion 302d of the handle 300. The housing 302 of the handle 300 encloses the actuation assembly 400 and provides ergonomic support for gripping and operational control.
[00106] A plurality of absorbable tacks 250A is housed in the longitudinal channel 214 of the inner tube 210. The coiled tube 220 is helically wrapped around the inner tube 210A and aligned with the longitudinal channel 214. The coils 222 of the coiled tube 220 engage with the lateral wings 252b of each tack 250A, securing them in place and guiding their movement during deployment. The first end 420c of the coupling element 420A is rotatably coupled to the rotating rod 412 of the driver 410. The second end 420d of the coupling element 420A is coupled to the proximal end of the inner tube 210A. Actuation is controlled via the actuator 430 disposed within the handle 300 and electrically connected to the processing unit 440 through a plurality of connecting wires 438. The processing unit 440 is configured to regulate the rotational output of the driver 410 for tack 250A deployment.
[00107] An alternative embodiment of the assembly of delivery device 100B is described below. Similar to delivery device 100A, the proximal ends of the inner tube 210B, the intermediate tube 230B, and the outer tube 240 are inserted into the delivery tube port 300d of the handle 300. The third slots 242 of the outer tube 240 and the second slots 232 of the intermediate tube 230B are fixedly secured to the plurality of fangs 308 provided in the second portion 302d of the handle 300. The housing 302 of the handle 300 supports the internal components of the actuation assembly 400.
[00108] The inner tube 210B accommodates a plurality of non-absorbable tacks 250B, each having a coiled member 258. Each tack 250B is individually mounted and seated within the cavity 214c of the inner tube 210B before the deployment. The coiled tube 220 is helically disposed over the inner tube 210B and is aligned with the coiled member 258 of the tacks 250B. The surface of the coils 222 of the coiled tube 220 is configured to laterally support and guide the rotational advancement of each tack 250B during deployment, while preventing premature displacement prior to actuation. The first end 420c of the coupling element 420B is rotatably attached to the rotating rod 412 of the driver 410, while its second end 420d is coupled to the proximal portion of the inner tube 210B. The driver 410 is controlled by the actuator 430, which is connected to the processing unit 440 via multiple connecting wires 438. The processing unit 440 governs the rotation of the driver 410 to initiate precise deployment of each tack 250B upon actuation.
[00109] An embodiment of the working of delivery device 100A is now described. The delivery device 100A is configured for the deployment of absorbable tacks 250A during surgical procedures. A plurality of tacks 250A is preloaded within the longitudinal channel 214 formed at the distal end of the inner tube 210A. These tacks 250A are laterally supported and axially aligned by the coils 222 of the coiled tube 220. To initiate deployment, the medical practitioner actuates the plunger 432 of the actuator 430. Pressing the plunger 432 closes the electrical circuit on the panel 436, prompting the processing unit 440 to send an instruction signal to the driver 410. Upon receiving the signal, the driver 410 initiates rotation of the rotating rod 412. This rotation is transferred through the coupling element 420A to the inner tube 210A. As the inner tube 210A rotates, the tack 250A held in the longitudinal channel 214 of inner tube 210A begins rotating in synchrony. The wings 252b of the tack 250A are guided along the helical path formed by the coils 222 of the coiled tube 220. This guided engagement enables the tack 250A to advance longitudinally in a screwing motion, anchoring it into the target tissue. After the first tack 250A is deployed, the next tack in the stack advances into position within the longitudinal channel 214. The display 442 of the processing unit 440 updates in real time to show the number of tacks 250A remaining within the system.
[00110] An embodiment of the working of delivery device 100B is now described. The delivery device 100B is configured for the deployment of non-absorbable tacks 250B, each having a coiled member 258, for fixation during surgical procedures. The tacks 250B are pre-positioned along the cavity 214c of the inner tube 210B. The coiled tube 220 is helically disposed around the distal portion of the inner tube 210B. The coils 222 of the coiled tube 220 interact with the coiled member 258 of the tack 250B. To deploy a tack 250B, the user presses the plunger 432 of the actuator 430. This action completes the circuit via the panel 436, causing the processing unit 440 to send a signal to the driver 410. The driver 410 rotates the rotating rod 412, and this rotation is transmitted via the coupling element 420B to the inner tube 210B. As the inner tube 210B rotates, the selected tack 250B rotates with it. The coiled member 258 of the tack 250B engages with the tissue of the target site. Once the tack 250B is fully deployed, the system positions the next tack 250B for deployment. The display 442 of the processing unit 440 tracks and displays the number of tacks remaining in the delivery device 100B.
[00111] The device of the present disclosure offers several advantages over conventional tacking instruments. Unlike traditional manual tackers that require significant manual effort and often result in inconsistent tack placement, the present device incorporates a motorized actuation assembly that enables precise, uniform, and consistent deployment of tack. Therefore, the device minimizes user fatigue and enhances the accuracy of tack insertion during both open and laparoscopic procedures. The device is capable of deploying both absorbable and non-absorbable tack using a single integrated platform, thereby eliminating the need for multiple specialized instruments for different tack types. This feature significantly improves surgical efficiency and provides procedural flexibility. Additionally, the integration of the processing unit with a display allows real-time monitoring of deployed and remaining tack, reducing the likelihood of intraoperative interruptions. The powered actuation mechanism enables faster tack deployment compared to manual systems, thereby reducing overall procedure time and enhancing procedural throughput. The device ensures controlled alignment and guided advancement of the tack, minimizing trauma to surrounding tissues. Thus, the device enhances patient safety, reduces recovery time, and improves clinical outcomes.
[00112] 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. , C , Claims:We claim
1. A delivery device (100) to deliver one or more tacks comprising:
a. a handle (300);
b. a delivery tube (200) coupled to a distal end of the handle (300), including:
i. an inner tube (210) including a proximal portion and a distal portion, the inner tube (210) including a slit extending at least partially in the distal portion of the inner tube (210) and configured to at least partially seat a plurality of tacks (250);
ii. a coiled tube (220) including a lumen provided over the plurality of tacks (250) at least partially seated in the slit of the inner tube (210);
iii. an intermediate tube (230) disposed over the proximal portion of the inner tube (210); and
iv. an outer tube (240) extending over the intermediate tube (230) and the coiled tube (220);
c. an actuation assembly (400) housed in the handle (300), including:
i. a driver (410) coupled to the inner tube (210); and
ii. a processing unit (440) configured to execute instructions to switch on the driver (410) upon receiving an actuation input;
wherein rotation of the inner tube (210) configures a tack (250) of the plurality of tacks (250) to exit the lumen of the coiled tube (220) upon a distal movement of the plurality of tacks (250).
2. The delivery device (100) as claimed in claim 1, wherein the inner tube (210A) comprises a first slot (212) at its proximal end and configured to couple with a coupling element (420A) of the actuation assembly (400) via a pin (422).
3. The delivery device (100) as claimed in claim 1, wherein the inner tube (210) comprises an anchor (210c) at its proximal end and configured to couple with a coupling element (420B) in an angled configuration.
4. The delivery device (100) as claimed in claim 1, wherein the coiled tube (220) comprises a plurality of coils (222) defining a helical path, the surface of each coil (222) configured to assist distal movement of a wing (252b) of the tack (250) along the helical path during deployment.
5. The delivery device (100) as claimed in claim 1, wherein the coiled tube (220) is fixedly coupled to the outer tube (240) and configured to remain stationary during rotation of the inner tube (210).
6. The delivery device (100) as claimed in claim 1, wherein the outer tube (240) includes a plurality of third slots (242) at a proximal end, the third slots (242) configured to engage with a plurality of fangs (308) disposed within the handle (300) for fixed coupling.
7. The delivery device (100) as claimed in claim 1, wherein the inner tube (210) comprises a longitudinal channel (214) in the distal portion that forms two opposing arms (214a, 214b), the longitudinal channel (214) configured to seat at least partially the plurality of tacks (250A).
8. The delivery device (100) as claimed in claim 1, wherein the inner tube (210) comprises a cavity (214c) disposed at its distal portion, the cavity (214c) configured to hold the plurality of tacks (250B).
9. The delivery device (100) as claimed in claim 1, wherein the actuation assembly (400) includes a coupling element (420) disposed within the handle (300) and configured to couple the driver (410) and the inner tube (210) of the delivery tube (200).
10. The delivery device (100) as claimed in claim 1, wherein the actuation assembly (400) includes an actuator (430) configured to receive an actuation input.
11. The delivery device (100) as claimed in claim 10, wherein the actuator (430) includes a plunger (432) that closes an electrical circuit upon actuation and activates the processing unit (440).
12. The delivery device (100) as claimed in claim 1, wherein the driver (410) comprises a rotating rod (412) configured to transmit torque to the inner tube (210) via the coupling element (420).
13. The delivery device (100) as claimed in claim 1, wherein a coupling element (420A) comprises a first lumen (420e) configured to receive the rotating rod (412) and a proximal end of an inner tube (210A).
14. The delivery device (100) as claimed in claim 1, wherein a coupling element (420B) comprises a second lumen (424) configured to receive the rotating rod (412) and a coupling groove (426) to couple an anchor (210c) of an inner tube (210B).
15. The delivery device (100) as claimed in claim 1, wherein the tacks (250A) comprise a base member (252), a spiral member (254) and a piercing tip (256).
16. The delivery device (100) as claimed in claim 15, wherein the base member (252) includes a plurality of wings (252b) extending laterally outwards from a proximal portion of the base member (252), each wing (252b) extends outwards beyond a longitudinal channel (214) provided with the inner tube (210A).
17. The delivery device (100) as claimed in claim 1, wherein the processing unit (440) is configured to regulate the rotational speed (RPM) of the driver (410) based on the type of tack (250), including:
a. an RPM range of 5–8 for absorbable tacks (250A); and
b. an RPM range of 3–7 for non-absorbable tacks (250B).
18. The delivery device (100) as claimed in claim 1, wherein the handle (300) includes a display opening (306a) configured to indicate the number of tacks (250) remaining to be deployed.