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:
ANASTOMOSIS DEVICE

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

3. The following specification particularly describes the invention and the manner in which it is to be performed:
 
FILED OF THE INVENTION
[001] The present disclosure relates to a medical device. More particularly, the present disclosure relates to an anastomosis device.
BACKGROUND OF THE INVENTION
[002] Anastomosis is a critical surgical procedure that involves connecting two tubular structures, such as blood vessels, intestines, etc., to restore continuity and function.
[003] The anastomosis procedure often relies on a two-step approach. The first step involves creating an opening, or "punch," in the tubular structure (e.g., in the aorta) and the subsequent step focuses on achieving temporary or permanent occlusion to control blood flow within the region of the opening.
[004] Conventionally, each step requires a separate tool or instrument, for example, the first step typically uses a dedicated puncturing or cutting instrument to prepare the vessel or tissue, while the second step may require a dedicated clamp-type device that physically occludes the vessel using a grasping mechanism, or manual compression techniques where surgeons directly compress the punched area with their fingers.
[005] Surgeons must switch between these two types of devices, increasing an overall procedure time. Surgeons must reposition and adjust different tools each time the devices are changed during the procedure, which is cumbersome for the surgeon. Repeated insertion and removal of different devices may cause mechanical irritation or trauma to surrounding tissues, leading to patient discomfort. Further, this may involve significant risk to the patient.
[006] Therefore, there arises a need for an anastomosis device to overcome the aforesaid problems.
SUMMARY OF THE INVENTION
[007] 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.
[008] The present disclosure relates to an anastomosis device. In an embodiment, the anastomosis device includes a plunger, a first punching element, a second punching element, a plug and an actuation assembly. The first punching element is partially disposed within a plunger lumen of the plunger. The second punching element is coupled to the plunger and is slidably disposed over the first punching element. The actuation assembly is coupled to the plug. The actuation assembly is configured to deploy the plug in a vessel. The first punching element and the second punching element are configured to create a puncture in the vessel. The plug is configured to toggle between an undeployed state and a deployed state. In the undeployed state, the plug is seated within a first lumen of the first punching element. In the deployed state, the plug is configured to occlude the puncture.
BRIEF DESCRIPTION OF DRAWINGS
[009] The summary above and the detailed description of descriptive embodiments, is better understood when read in conjunction with the apportioned drawings. For illustration of 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.
[0010] Fig. 1a depicts an anastomosis device 100, according to an embodiment of the present disclosure.
[0011] Fig. 1b depicts a section view the anastomosis device 100, according to an embodiment of the present disclosure.
[0012] Fig. 2 depicts a perspective view of a handle 122 of the anastomosis device 100, according to an embodiment of the present disclosure.
[0013] Fig. 3a depicts a perspective view of a plunger 124 of the anastomosis device 100, according to an embodiment of the present disclosure.
[0014] Fig. 3b depicts cross-sectional views of the plunger 124 of the anastomosis device 100, according to an embodiment of the present disclosure.
[0015] Fig. 3c depicts an assembled view of a punching assembly 120 of the anastomosis device 100, according to an embodiment of the present disclosure.
[0016] Fig. 4 depicts a first punching element 126 of the anastomosis device 100, according to an embodiment of the present disclosure.
[0017] Fig. 5 depicts a second punching element 128 of the anastomosis device 100, according to an embodiment of the present disclosure.
[0018] Fig. 6 depicts a bush 130 of the anastomosis device 100, according to an embodiment of the present disclosure.
[0019] Fig. 7 depicts a locking pin 180 of the anastomosis device 100, according to an embodiment of the present disclosure.
[0020] Fig. 8a depicts a side view of a plugging assembly of the anastomosis device 100, according to an embodiment of the present disclosure.
[0021] Figs. 8b-8d depict various components of an actuation assembly 220 of the plugging assembly, according to an embodiment of the present disclosure.
[0022] Fig. 9a depicts coupling between a plug 200 and the actuation assembly 220 of the plugging assembly according to an embodiment of the present disclosure.
[0023] Fig. 9b depicts a perspective view of the plug 200 in a closed state, according to an embodiment of the present disclosure.
[0024] Fig. 9c depicts a cross-sectional view of the plug 200 in the closed state, according to an embodiment of the present disclosure.
[0025] Fig. 10 depicts an exemplary method 1000 to use the anastomosis device 100, according to an embodiment of the present disclosure.
[0026] Fig. 11a depicts a rim 126d of the first punching element 126 of the punching assembly 120 inserted into a vessel 500, according to an embodiment of the present disclosure.
[0027] Fig. 11b depicts an actuation assembly 220 in an unactuated state, according to an embodiment of the present disclosure.
[0028] Fig. 12a depicts the plug 200 exposed in the vessel 500, according to an embodiment of the present disclosure.
[0029] Fig. 12b depicts the plug 200 in an expanded configuration in the vessel 500, according to an embodiment of the present disclosure.
[0030] Fig. 12c depict an actuated state of an actuation assembly 220, according to an embodiment of the present disclosure.
[0031] Fig. 13 depicts an actuated state of the punching assembly 120, according to an embodiment of the present disclosure.
[0032] Fig. 14a depicts a separation of the punching assembly 120 from the plugging assembly, according to an embodiment of the present disclosure.
[0033] Fig. 14b depicts the separated punching assembly 120 and the plugging assembly, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF ACCOMPANYING DRAWINGS
[0034] Prior to describing the disclosure 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.
[0035] 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.
[0036] 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.
[0037] 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.
[0038] The present disclosure relates to an anastomosis device (or device). The device may be used by medical practitioners to create rapid and compliant anastomoses as required in a surgical procedure, for example, during coronary artery surgery.
[0039] The device of the present disclosure helps to create a puncture in a vascular tissue and then helps the medical practitioner create an anastomosis using the said puncture. In an embodiment, the device integrates a punching assembly and a plugging assembly. The punching assembly is intended to create the puncture and the plugging assembly is used for temporary occlusion of the puncture while the medical practitioner sutures the tissues. The plugging assembly includes a plug to occlude the puncture and an actuating assembly to actuate the plug (e.g., to expand the plug). The integration of the punching assembly and the plugging assembly in a single device eliminates the need to switch between multiple instruments during an anastomosis procedure. Consequently, the procedure of creating anastomoses becomes relatively easy for the medical practitioner and time efficient.
[0040] Further, with the integration of the punching assembly and the plugging assembly in the device, alignment between the puncture site and occlusion zone is inherently coordinated. This ensures quicker mechanical stabilization of the puncture site by promptly sealing the opening, thereby minimizing blood leakage and tissue movement, and facilitating a smoother and safer anastomosis procedure. By minimizing tool exchanges and maintaining continuous control over the site, the risk of inadvertent bleeding or tissue damage is reduced.
[0041] Now referring to the figures, Fig. 1a depicts an exemplary anastomosis device 100 (hereinafter, referred to as device 100) of the present disclosure. Fig. 1b depicts a cross-sectional view of the device 100. The device 100 includes a proximal end 100a and a distal end 100b. In an exemplary embodiment, the device 100 includes a punching assembly 120 and a plugging assembly.
[0042] The punching assembly 120 of the device 100 helps to create a puncture in a vascular tissue. The punching assembly 120 includes, without limitation, a handle 122, a plunger 124, a first punching element 126, a second punching element 128, a bush 130, at least one resilient element 134 and a locking pin 180.
[0043] The plugging assembly helps the medical practitioner to create a haemostatic seal at the puncture (created by the punching assembly 120) while the medical practitioner sutures the puncture to create an anastomosis. The plugging assembly includes a plug 200 and an actuation assembly 220 configured to actuate the plug 200, e.g., toggle the plug 200 between a closed state (also referred to as a collapsed configuration or an undeployed state) and an open state (also, referred to as an expanded configuration or a deployed state). In an embodiment, the actuation assembly 220 includes, without limitation, a rod 222, a tube 224, and a locking member 228.
[0044] Fig. 2 depicts the handle 122 of the punching assembly 120, according to an embodiment of the present disclosure. The handle 122 allows a surgeon to hold the device 100. The handle 122 includes a proximal end 122a and the distal end 122b. The handle 122 may have a predefined length ranging between 155mm and 165mm. In an embodiment, the predefined length of the handle 122 is 160mm.
[0045] The handle 122 is hollow, thereby defining a handle lumen 122c. The handle lumen 122c extends between the proximal end 122a and the distal end 122b of the handle 122 (i.e., for an entire length of the handle 122). The handle lumen 122c is configured to at least partially house various components of the device 100, which has been explained later. The handle lumen 122c may have a predefined diameter ranging between 9 mm and 12 mm. In an embodiment, the predefined diameter of the handle lumen 122c is 10 mm.
[0046] In an embodiment, at least a portion of an outer surface of the handle 122 is provided with a plurality of ridges 122d (hereinafter, ridges 122d). In an embodiment, the ridges 122d are formed using molding, though any other technique may be used. The ridges 122d may be formed in a predefined pattern, such as, without limitation, slant, crisscross, etc. In an embodiment, the ridges 122d are formed in crisscross pattern. The ridges 122d helps the medical practitioner to have a better grip on the device 100 while holding the device 100.
[0047] In the depicted embodiment, the handle 122, towards the proximal end 122a, is provided with two wings 122e. In an embodiment, the wings 122e are provided opposite to each other. In the depicted embodiment, each wing 122e is generally inverted L-shaped, though they may have any other suitable shape. The wings 122e provide a better grip over the handle 122.
[0048] The handle 122, towards the distal end 122b, is provided with at least one hole 122f. In an exemplary embodiment, the handle 122 is provided with a pair of holes 122f disposed diametrically opposite to each other. The pair of holes 122f are configured to at least partially receive the locking pin 180 (as shown in Fig. 1a). The pair of holes 122f are shaped and dimensioned corresponding to the locking pin 180.
[0049] The handle 122 may be made of a material including, but not limited to, Acrylonitrile butadiene styrene (ABS), Polypropylene, Polycarbonate (PC), Polyethylene, etc. In an exemplary embodiment, the handle 122 is made of ABS. The handle 122 may have a pre-defined cross-section including, but not limited to, cylindrical, elliptical, square, triangular, or combination thereof. In an exemplary embodiment, as shown in Fig. 2, the handle 122 has a rectangular cross-section.
[0050] The handle 122 depicted herein should be considered as exemplary. A person skilled in the art will appreciate that numerous variations to the handle 122 can be made for achieving the same function while practicing the inventive features of the present disclosure and the same are within the scope of the present disclosure.
[0051] Figs. 3a-3b depict the plunger 124 of the punching assembly 120, according to an embodiment of the present disclosure. The plunger 124 includes a proximal end 124a and a distal end 124b. A portion of the plunger 124 is disposed within the handle lumen 122c of the handle 122. In an embodiment, a proximal portion of the plunger 124 protrudes out from the proximal end 122a of the handle 122. The distal end 124b of the plunger 124 protrudes out from the distal end 122b of the handle 122. The plunger 124 is slidable within the handle lumen 122c. The plunger 124 may have a predefined length and an outer diameter. The outer diameter of the plunger 124 may correspond to the diameter of the handle lumen 122c. The predefined length and the outer diameter of the plunger 124 may range between 160 mm and 175 mm, and 9 mm and 10 mm, respectively. In an embodiment, the predefined length and the predefined outer diameter of the plunger 124 are 167 mm and 9.5 mm, respectively.
[0052] The plunger 124 is hollow, thereby, defining a plunger lumen 124c. In an embodiment, the plunger lumen 124c has stepped configuration, thereby dividing the plunger lumen 124c into a first section A, a second section B and a third section C, as shown in Figs. 3a-3b. In an embodiment, the first section A and the second section B are provided towards the proximal end 124a and distal end 124b of the plunger lumen 124c, respectively. The third section C is provided between the first section A and the second section B. Each section of the plunger lumen 124c has a respective diameter. In an embodiment, the first section A of the plunger lumen 124c is the narrowest, the second section B is the broadest, and a diameter of the third section C is larger than a diameter of the first section A and smaller than a diameter of the second section B. The diameter of the first section A, the second section B and the third section C may range between 3 mm and 4 mm, 8 mm and 8.5 mm, and 7 mm and 7.6 mm, respectively. In an exemplary embodiment, the diameters of the first section A, the second section B and the third section C are 3.4 mm, 8.3 mm and 7.4 mm, respectively.
[0053] The stepped configuration is designed to create a plurality of flanges. For example, the transition between the first section A and the third section C defines a first flange 124c1. Similarly, the transition between the second section B and the third section C defines a second flange 124c2.
[0054] The plunger 124, at the proximal end 124a, is provided with an annular flange 124d. The annular flange 124d is provided around a circumference of the plunger 124. The annular flange 124d helps the medical practitioner to actuate, e.g., push, the plunger 124 towards the distal end 124b for creating the puncture in the vascular tissue (described later).
[0055] The plunger 124, towards the distal end 124b, is provided with at least one elongated hole 124f. Specifically, the at least one elongated hole 124f is provided in the third section C towards the second flange 124c2. In an exemplary embodiment, as shown in Fig. 3a, the plunger 124 includes a pair of elongated holes 124f provided diametrically opposite to each other. The pair of elongated holes 124f at least partially aligns with the pair of holes 122f of the handle 122. In an embodiment, the elongated hole 124f is axially longer than the hole 122f of the handle 122. The pair of elongated holes 124f is configured to at least partially receive the locking pin 180. The pair of elongated holes 124f allows the plunger 124 to slide with respect to the handle 122. The extent of relative sliding between the handle 122 and the plunger 124 is dependent on the axial length of the elongated hole 124f. For example, the plunger 124 is able to slide for a distance equal to the axial length of the elongated hole 124f. The axial length of the elongated hole 124f may range between 9.5 mm and 10 mm. In an embodiment, the axial length of the elongated hole 124f is 9.7 mm. The relative sliding between the handle 122 and the plunger 124 helps the medical practitioner to create the puncture (described later).
[0056] The plunger 124 may be made of a material including, but not limited to, Acrylonitrile butadiene styrene (ABS), Polypropylene, Polycarbonate (PC), Polyethylene, etc. In an exemplary embodiment, the plunger 124 is made of ABS. The plunger 124 may have a pre-defined cross-sectional shape including, but not limited to, cylindrical, elliptical, square, triangle, etc. In an exemplary embodiment, the plunger 124 is cylindrical, i.e., has a circular cross-section, as shown in Figs. 3a-3b.
[0057] Referring to Fig. 3c, in an embodiment, the first punching element 126, the second punching element 128 and the bush 130 are at least partially disposed within the plunger lumen 124c. Specifically, the second punching element 128 is partially disposed in the second section B, the first punching element 126 is partially disposed in the second section B and the third section C of the plunger lumen 124c, and the at least one resilient element 134 and the bush 130 are fully disposed in the third section C of the plunger lumen 124c.
[0058] An exemplary first punching element 126 is depicted in Fig. 4. The first punching element 126 includes a proximal end 126a and a distal end 126b. The first punching element 126 is configured to create the puncture. The distal end 126b of the first punching element 126 protrudes out of the distal end 124b of plunger 124, as shown in Fig. 3c.
[0059] The first punching element 126 may have a pre-defined cross-sectional shape including, but not limited to, circular, square, triangle, etc. In an exemplary embodiment, as shown in Fig. 4, the first punching element 126 is cylindrical, i.e., has a circular cross-section.
[0060] The first punching element 126 may have a uniform or non-uniform cylindrical body. In an exemplary embodiment, the first punching element 126 has a non-uniform cylindrical body. In an embodiment, the first punching element 126 includes a proximal portion 126a1 provided/disposed at the proximal end 126a, a distal portion 126b1 provided/disposed at the distal end 126b and a middle portion 126a2 provided therebetween. The proximal portion 126a1 is broader than the distal portion 126b1 and the middle portion 126a2, i.e., a diameter of the proximal portion 126a1 is larger than a diameter of the distal portion 126b1 and the middle portion 126a2. The middle portion 126a2 has a larger diameter than a diameter of the distal portion 126b1. In an embodiment, the distal portion 126b1 protrudes out from the plunger lumen 124c. In other words, the distal portion 126b1 is disposed outside the plunger lumen 124c. The proximal portion 126a1 and a proximal section of the middle portion 126a2 of the first punching element 126 is disposed within the third section C of the plunger lumen 124c. A distal part of the middle portion 126a2 is disposed in the second section B of the plunger lumen 124c.
[0061] The first punching element 126 is hollow, thus, defining a first lumen 126c. The first lumen 126c is configured to receive a portion of the tube 224 of the actuation assembly 220 (explained later).
[0062] In an embodiment, the first punching element 126 includes a rim 126d provided at the distal end 126b. The rim 126d is disposed/positioned outside of the plunger lumen 124c. The rim 126d is provided circumferentially. The rim 126d is configured to penetrate the vascular wall and reside within the vessel and contact an inner surface of the vascular wall during the anastomosis procedure. The rim 126d helps the medical practitioner to position the device 100 at the vascular wall where the puncture is to be created. The rim 126d facilitate vascular wall engagement during a surgical procedure and allows for improved grasping and stabilization of the vascular tissue during a punching operation. The rim 126d has a predefined shape, such as, without limitation, dome, hemispherical, frustum, conical, etc. In an embodiment, the rim 126d is dome-shaped, reducing trauma to the vascular tissue. A proximal diameter of the rim 126d is larger than the diameter of the distal portion 126b1. The proximal diameter of the rim 126d may range between 5 mm and 5.7 mm. In an example implementation, the proximal diameter of the rim 126d is 5.45 mm. A proximal face of the rim 126d contacts the inner surface of the vascular wall and helps in creating the puncture as explained later.
[0063] The first punching element 126 may be made of a material including, but not limited to, nitinol, platinum, stainless steel 305 (SS305), stainless steel 304 (SS304), stainless steel 316 (SS316), copper, titanium, etc. In an exemplary embodiment, the first punching element 126 is made of stainless steel 316 (SS316).
[0064] The first punching element 126, towards the proximal end 126a, is provided with at least one hole 126f. In an exemplary embodiment, as shown in Fig. 4, the first punching element 126 is provided with a pair of holes 126f disposed diametrically opposite to each other. The pair of holes 126f aligns with the pair of holes 122f of the handle 122 and is configured to at least partially receive the locking pin 180. The hole 126f is shaped and dimensioned corresponding to the locking pin 180.
[0065] The second punching element 128 is coupled to the plunger 124 using adhesive bonding, though other suitable coupling technique may be used. In an embodiment, the second punching element 128 is slidably disposed over the first punching element 126 and within the second section B of the plunger lumen 124c. In an embodiment, the second punching element 128 is disposed over the middle portion 126a2 of the first punching element 126. In other words, the second section B is configured to receive the second punching element 128 such that the second punching element 128 is disposed between an outer surface of the middle portion 126a2 of the first punching element 126 and an inner surface of the second section B of the plunger lumen 124c. Fig. 5 depicts the second punching element 128 according to an embodiment. Together, the first punching element 126 and the second punching element 128 are configured to create the puncture in the vessel, as explained later. The second punching element 128 includes a proximal end 128a and a distal end 128b. A proximal face of the second punching element 128 is coupled with the second flange 124c2 of the plunger 124 (as shown in Fig. 3c), for example, using adhesive bonding. The second punching element 128 includes a tapered portion 128d towards the distal end 128b. A diameter of the tapered portion 128d decreases from a proximal to a distal end of the tapered portion 128d. In other words, the tapered portion 128d has a maximum diameter at the proximal end and a minimum diameter at the distal end. The maximum diameter and the minimum diameter at the proximal end and the distal end of the tapered portion 128d may range between 7.5 mm and 8 mm, and 5.3 mm and 5.7 mm, respectively. In an embodiment, the maximum diameter and the minimum diameter of the tapered portion 128d are 7.8 mm and 5.5 mm, respectively.
[0066] The tapered portion 128d of the second punching element 128 protrudes out from the distal end 124b of the plunger 124, as shown in Fig. 3c. The distal end 128b of the second punching element 128 is positioned between the distal end 124b of the plunger 124 and the distal end 126b of the first punching element 126. Further, in a normal state (or an unactuated state) of the punching assembly 120, the distal end 128b of the second punching element 128 is disposed proximal to the distal end 126b of the first punching element 126 by a predefined distance as shown in Fig. 3c.
[0067] The second punching element 128 generally has a hollow, tubular structure (i.e., has a circular cross-section), defining a second lumen 128c. The second lumen 128c is configured to receive a portion of the first punching element 126. An internal diameter of the second punching element 128 may correspond to an outer diameter of the first punching element 126. An external diameter of the second punching element 128 may correspond to an inner diameter of the plunger lumen 124c at the second section B. The internal diameter and the external diameter of the second punching element 128 may range between 5.3 mm and 5.7 mm, and 7.5 mm and 8 mm, respectively. In an embodiment, the internal diameter and the external diameter of the second punching element 128 are 5.5 mm and 7.8 mm, respectively.
[0068] During operation of the device 100, the vascular wall is disposed (or sandwiched) between the distal face of the second punching element 128 and the first punching element 126. In response to the actuation of the plunger 124 (such as, pressing annular flange 124d of the plunger 124), the plunger 124 moves in a distal direction and due to the coupling between the second punching element 128 and the plunger 124, the second punching element 128 too is configured to move in the distal direction. The second punching element 128 is configured to slide over the first punching element 126 in the distal direction for a predefined length in response to the actuation of the plunger 124. A distal face of the second punching element 128 comes into contact with the proximal face of the rim 126d of the first punching element 126, pressing the vascular wall therebetween and creating the puncture. The predefined length traversed by the second punching element 128 is defined by a length of the distal portion 126b1 of the first punching element 126. The length of the distal portion 126b1 of the first punching element 126 may range between 8 mm and 9.5 mm. In an embodiment, the length of the distal portion 126b1 of the first punching element 126 is 9 mm.
[0069] The second punching element 128 may have a length ranging between 33 mm and 37 mm. In an embodiment, the length of the second punching element 128 is 35 mm. The second punching element 128 may be made of material, such as, without limitation, stainless steel (SS316), titanium, etc. In an embodiment, the second punching element 128 is made of SS316.
[0070] As shown in Fig. 3c, the bush 130 is disposed proximal to the first punching element 126 and within the plunger lumen 124c. Specifically, the bush 130 is disposed within the third section C of the plunger lumen 124c. Fig. 6 depicts the bush 130 according to an embodiment.
[0071] The bush 130 includes a proximal end 130a and a distal end 130b. The bush 130 includes a bush lumen 130c extending from the proximal end 130a to the distal end 130b. The bush lumen 130c is configured to receive a portion of the tube 224 of the actuation assembly 220 (explained later).
[0072] In an embodiment, the bush 130 includes a head 130d at the distal end 130b and a body 130e extending from the head 130d to the proximal end 130a. As shown in Fig. 3c, the head 130d of the bush 130 abuts the proximal face at proximal end 126a of the first punching element 126. More specifically, a distal face of the head 130d of the bush 130 abuts a proximal face of the first punching element 126. In an embodiment, the head 130d and the body 130e are cylindrical and a diameter of the head 130d is larger than a diameter of the body 130e. The body 130e of the bush 130 has a diameter less than a diameter of the third section C of the plunger lumen 124c. The diameter of the head 130d of the bush 130 corresponds to the diameter of the third section C.
[0073] The bush 130 may be made of a material including, but not limited to, Acrylonitrile butadiene styrene (ABS), Polypropylene, Polycarbonate (PC), Polyethylene, etc. In an exemplary embodiment, the bush 130 is made of ABS. The bush 130 may have a pre-defined cross-sectional shape including, but not limited to, circular, square, triangle, etc. In an exemplary embodiment, as shown in Fig. 6, the bush 130 is cylindrical, i.e., has a circular cross-section.
[0074] In an embodiment, at least one resilient element 134 (hereinafter, resilient element 134) is wrapped around the body 130e of the bush 130 as depicted in Fig. 3c such that the resilient element 134 is disposed between the outer surface of the body 130e of the bush 130 and the inner surface of the plunger lumen 124c (as shown in Fig. 3c). The resilient element 134 extends between the first flange 124c1 and a proximal face of the head 130d of the bush 130. The resilient element 134 abuts the head 130d of the bush 130 and the first flange 124c1 of the plunger 124. The bush 130 prevents the migration of the at least one resilient element 134 from the third section C into the second section B. The resilient element 134 is configured to provide resilience to the movement of the plunger 124 upon actuation of the plunger 124 (e.g., in response to the annular flange 124d of the plunger 124 being pushed). This helps the plunger 124 to return quickly to an initial position after being pressed.
[0075] The locking pin 180 is depicted in Fig. 7. The locking pin 180 is disposed across the holes 122f of the handle 122, the elongated holes 124f of the plunger 124, and the holes 126f of the first punching element 126. The elongated holes 124f of the plunger 124 are at least partially aligned with the holes 126f of the first punching element 126 and the holes 122f of the handle 122. The holes 122f of the handle 122 the elongated holes 124f of the plunger 124 and the holes 126f of the first punching element 126 are configured to receive the locking pin 180. The locking pin 180 is configured to lock the handle 122 and the first punching element 126 and prevent any relative movement between the handle 122 and the first punching element 126. Thus, locking pin 180 fixates the handle 122 and the first punching element 126 at a respective place and allows a limited axial motion of the plunger 124 within the range defined by the elongated holes 124f. In other words, the first punching element 126 and the handle 122 are immovable with respect to the movement of the plunger 124. The plunger 124 is movable within the range without disturbing the alignment of the handle 122 and the first punching element 126. This ensures a precise operation of the device 100 without any unwanted movements.
[0076] As shown in Fig. 7, the locking pin 180 is provided with a hole 180a. The hole 180a is co-axial with the first lumen 126c and provides passage for the tube 224 of the actuation assembly 220.
[0077] The locking pin 180 may be made of a material including, but not limited to, titanium, cobalt-chrome, magnesium, platinum, gold, stainless steel 305 (SS305), stainless steel 304 (SS304), stainless steel 3016 (SS316), etc. In an exemplary embodiment, the locking pin 180 is made of SS305. The locking pin 180 may have a pre-defined shape, including, but not limited to, cylindrical, cuboidal, prism, etc. In an exemplary embodiment, as shown in Fig. 5, the locking pin 180 is cuboidal.
[0078] Figs. 8a-8d depict the plugging assembly, according to an embodiment of the present disclosure.
[0079] The rod 222 of the actuation assembly 220 includes a proximal end 222a and a distal end 222b, as shown in Figs. 8a-8b. The proximal end 222a and the distal end 222b of the rod 222 are coupled to the locking member 228 and the plug 200, respectively (explained later). The rod 222 may have a predefined length ranging between 290 mm and 350 mm. In an embodiment, the length of the rod 222 is 330 mm. The rod 222 is partially disposed within the tube 224 such that the proximal end 222a of the rod 222 protrudes out proximally from the tube 224 and the distal end 222b of the rod 222 protrudes out distally from the tube 224. In an embodiment, the rod 222 includes a protrusion 222c provided towards the proximal end 222a, as shown in Fig. 8b. The protrusion 222c helps in locking the plug 200 in the undeployed or deployed state (explained later).
[0080] The rod 222 may have a pre-defined shape including, but not limited to, cylindrical, cuboidal, etc. In an exemplary embodiment, as shown in Fig. 8b, the rod 222 is cylindrical. The rod 222 may be made of a material including, but not limited to, titanium, cobalt-chrome, magnesium, platinum, gold, stainless steel 305 (SS305), stainless steel 304 (SS304), stainless steel 316 (SS316), etc. In an exemplary embodiment, the rod 222 is made of SS305.
[0081] An exemplary locking member 228 is depicted in Fig. 8c. In an embodiment, the locking member 228 is in the form of a knob. In an embodiment, the locking member 228 includes a head 228a and a spindle 228b. The head 228a may include a peripheral surface that may be textured or contoured to provide a better grip to the user. The spindle 228b extends from the head 228a.
[0082] The locking member 228 is removable coupled to the proximal end 222a of the rod 222. The locking member 228 may be coupled to the rod 222 using techniques, such as, without limitation, thread coupling technique, snap-fit, etc. In an exemplary embodiment, the locking member 228 is coupled to the rod 222 using a threaded coupling. For example, the spindle 228b may be threaded or semi-threaded. A plurality of threads may be provided on an inner surface or an outer surface of the spindle 228b. The plurality of threads is configured to mate with corresponding threads provided on the rod 222, thereby coupling the locking member 228 with the rod 222. In the depicted embodiment, the spindle 228b of the locking member 228 includes internal threads configured to mate with external threads provided on the rod 222. The locking member 228 prevents the punching assembly 120 from sliding over the actuation assembly 220. The locking member 228 and the rod 222 are decoupled before separating the punching assembly 120 and the actuation assembly 220 of the device 100 (explained later). In other words, the locking member 228 is de-coupled from the rod 222 to facilitate separating the punching assembly 120 from the actuation assembly 220.
[0083] The tube 224 of the actuation assembly 220 is depicted in Figs. 8a and 8d according to an embodiment. The tube 224 includes a proximal end 224a and a distal end 224b. The proximal end 224a and the distal end 224b of the tube 224 are coupled to the rod 222 and the plug 200, respectively. The tube 224 is partially disposed within the first section A of the plunger lumen 124c, the first lumen 126c and the bush lumen 130c. An outer diameter of the tube 224 corresponds to the diameter of the first section A of the plunger lumen 124c, the first lumen 126c and the bush lumen 130c. The tube 224 generally has a hollow, cylindrical structure, defining a tube lumen (not shown) extending between the proximal end 224a and the distal end 224b. The tube lumen is configured to receive a portion of the rod 222. An outer diameter of the rod 222 corresponds to a diameter of the tube lumen.
[0084] The rod 222 is slidably disposed within the tube 224. In an embodiment, the tube 224 includes a longitudinal slot 224c. The longitudinal slot 224c is provided towards the proximal end 224a of the tube 224. The longitudinal slot 224c is configured to receive the protrusion 222c of the rod 222, as shown in Figs. 8b and 8d. In other words, the protrusion 222c of the rod 222 is slidably disposed within the longitudinal slot 224c of the tube 224. The longitudinal slot 224c has a proximal end and a distal end. In an embodiment, the proximal end of the longitudinal slot 224c aligns with the proximal end 224a of the tube 224, such that the longitudinal slot 224c is open-ended at its proximal end. Such a construction enables assembling/disassembling the rod 222 with/from the tube 224. In another embodiment, the proximal end of the longitudinal slot 224c may be spaced from the proximal end 224a of the tube 224.
[0085] The protrusion 222c of the rod 222 is movable between a proximal and a distal end of the longitudinal slot 224c. In an embodiment, the protrusion 222c is movable within the longitudinal slot 224c, at least, between a first position and a second position. The first position is distal to the second position. The first position and the second position are disposed towards the distal end and the proximal end of the longitudinal slot 224c, respectively. In an embodiment, the first position aligns with the distal end of the longitudinal slot 224c and the second position is disposed at a distance from the proximal end of the longitudinal slot 224c, as shown in Fig. 8d. It should be understood that the first and second positions may be located at any other position between the proximal and distal ends of the longitudinal slot 224c. In an embodiment, the longitudinal slot 224c includes a proximal groove X provided towards the proximal end of the longitudinal slot 224c and a distal groove Y provided at the distal end of the longitudinal slot 224c. For example, the proximal groove X and the distal groove Y are provided at the second position and the first position of the protrusion 222c in the longitudinal slot 224c, respectively. The grooves X, Y extend laterally. The grooves X, Y are configured to lock the protrusion 222c at the second and first position, respectively, and prevent longitudinal movement of the rod 222. The rod 222 is rotated in a predefined direction to lock or unlock the protrusion 222c from the grooves X, Y. For example, the rod 222 is rotated in an anticlockwise direction to unlock the protrusion 222c from the grooves X, Y and in a clockwise direction to lock the protrusion 222c from the grooves X, Y, or vice versa.
[0086] Figs. 9a to 9c depict an exemplary plug 200 of the present disclosure. The plug 200 is configured to toggle between an expanded configuration (also, referred to as an open state or a deployed state) and a collapsed configuration (also, referred to as a closed state or an undeployed state). The plug 200 has a proximal end 200a and a distal end 200b. The plug 200 may have a predefined shape in the expanded configuration and the collapsed configuration. In an embodiment, the plug 200 has a hemispherical shape (e.g., cup or umbrella shape) in the open state (shown in Figs. 9a). In the closed state, the plug 200 has a compact radial profile for easier insertion and extraction of the plug 200 into or from the vessel (shown in Fig. 9b). For example, the plug 200 has a cylindrical or ellipsoid or drum-like shape in the closed state. It is possible that the plug 200 may have any other shapes in the open or closed state based upon the requirements, and the same are covered within the scope of the present disclosure. In the open state, the plug 200 is configured to occlude the vascular tissue. To move the plug 200 from the undeployed state to the deployed state either the proximal end 200a is moved closer to the distal end 200b or the distal end 200b is moved closer to the proximal end 200a. In an embodiment, the distal end 200b of the plug 200 is moved towards the proximal end 200a of the plug 200 with the help of the actuation assembly 220 as explained later. In the deployed state, the plug 200 is configured to occlude the puncture.
[0087] The plug 200 includes a frame 202 and a sealing member 215. The proximal end 200a and the distal end 200b of the plug 200 are coupled to the distal end 224b of the tube 224 and distal end 222b of the rod 222, respectively (explained later).
[0088] The frame 202 includes a proximal end 202a and a distal end 202b. The proximal end 202a and the distal end 202b are coupled to the actuation assembly 220 (explained later). In the undeployed state, the frame 202 is in the collapsed configuration. In the deployed state, the frame 202 is in the expanded configuration. The frame 202 may be made of one or more biocompatible materials, such as, without limitation, titanium, titanium alloys, shape memory polymers, cobalt-chromium alloy, etc. In an embodiment, the frame 202 is made of nitinol. The frame 202 is configured to provide structural support to the plug 200 and help in maintaining the shape of the plug 200 in the open and closed state. The frame 202 is configured to toggle between the undeployed state and the deployed state.
[0089] In an embodiment, the frame 202 includes a plurality of filaments 204 (hereinafter, filaments 204) braided in a pre-defined pattern to form a mesh. The predefined pattern includes, without limitations, 1:1, 1:2, 2:1, etc. In an embodiment, the filaments 204 are braided in 1:1 pattern. A braiding angle between adjacent filaments 204 may be chosen based upon requirements. In an embodiment, the braiding angle may range between 125 degrees and 127 degrees. In an embodiment, the braiding angle between adjacent filaments 204 is 126 degrees. In an embodiment, the filaments 204 are spirally braided. The filaments 204 have a proximal end and a distal end, defining a predefined length. The filaments 204 may have a predefined cross-section, such as, rectangular, circular, etc. In an embodiment, the filaments 204 have a circular cross-section having a predefined width and diameter.
[0090] The dimensions of the filaments 204 may be chosen based upon the target vessel. In an embodiment, the predefined length and diameter of the filaments 204 may range between 20 mm and 30 mm and 0.1 mm and 0.4 mm, respectively. In an example implementation, the predefined length and diameter of each filament 204 is 25 mm and 0.2 mm, respectively. The number of filaments 204 may be chosen based upon clinical requirements and/or the diameter of each filament 204. In an embodiment, the number filaments 204 may range between 12 and 36. In an embodiment, the number of filaments 204 are 24.
[0091] The frame 202 is configured to be toggled between the undeployed state and the deployed state, to configure the plug 200 in the undeployed and deployed state, respectively. In an embodiment, in the undeployed state or the collapsed configuration, the frame 202 has a first predefined length and in the deployed state or the expanded configuration, the frame 202 has a second predefined length. In an embodiment, the first predefined length of the frame 202 is larger than the second predefined length of the frame 202. The first predefined length corresponds to the maximum length of the frame 202 and the second predefined length corresponds to the minimum length of the frame 202. In another embodiment, in the collapsed configuration, the frame 202 is radially compressed and in the expanded configuration, the frame 202 is radially expanded. In an embodiment, in the undeployed state, the proximal ends and the distal ends of the filaments 204 are spaced apart from each other. the frame 202 includes a proximal portion 202c and a distal portion 202d of the frame 202 disposed towards the proximal end 202a and the distal end 202b of the frame 202, respectively. The proximal portion 202c and the distal portion 202d have a transition boundary T therebetween. In the undeployed state, the proximal portion 202c and the distal portion 202d of the frame 202 are non-overlapping, as shown in Fig. 9b. In an embodiment, the proximal portion 202c and the distal portion 202d have equal length, i.e., the transition boundary T is located at half-length of the frame 202. It is possible that the proximal portion 202c and the distal portion 202d may have different lengths. Each of the proximal portion 202c and the distal portion 202d may generally have a frustrum shape. In an embodiment, a diameter of the proximal portion 202c increases from the proximal end 202a of the frame 202 to transition boundary T. Similarly, a diameter of the distal portion 202d increases from the distal end 202b of the frame 202 to the transition boundary T. In the undeployed state, the filaments 204 are in taut position and the frame 200 is in the collapsed configuration. In the deployed state, the proximal ends and the distal ends of the filaments 204 are disposed adjacent to each other, causing the filaments 204 to be folded at the transition boundary T and shortening the length of the frame 200, creating the expanded configuration of the frame 202. In an embodiment, the distal end 202b of the frame 202 is moved towards the proximal end 202a of the frame 202 to toggle the frame 202 to the deployed state. As the distal end 202b of the frame 202 moves towards the proximal end 202a of the frame 202, the frame 202 folds at the transition boundary T such that the proximal portion 202c is disposed inside the distal portion 202d, and overlaps with the distal portion 202d, as shown in Fig. 9a, in the deployed state. In other words, in the deployed state, the proximal portion 202c is disposed inside the distal portion 202d. The first predefined length of the frame 202 may range between 17 mm and 23 mm. The second predefined length of the frame 202 may range between 6 mm and 8 mm. In an embodiment, the first predefined length and the second predefined length of the frame 202 are 22 mm and 7 mm, respectively. In an embodiment, the diameter of the frame 202 remains the same in both the undeployed and deployed states. The frame 202 has a predefined diameter, e.g., ranging from 6 mm to 8 mm. In an example implementation, the frame 202 has a diameter of 7 mm. It should be noted that the frame 202 formed by braiding the filaments 204 as described herein is merely exemplary. The frame 202 may have any other structure and may be formed using any other technique. For example, the frame 202 may include a plurality of struts arranged in a predefined pattern and may be formed by laser cutting a tube.
[0092] The sealing member 215 is disposed within the frame 202. The sealing member 215 is configured to provide sealing at a site of the puncture (i.e., at the puncture) and prevents leakage of blood. Thus, the sealing member 215 provides a leak-proof seal for the plug 200. The sealing member 215 may cover at least partial portion the frame 202 and may be coupled to an inner surface of the frame 202. In an embodiment, the sealing member 215 is provided within the frame 202 and is coupled to the inner surface of the frame 202 at the transition boundary T, as shown in Fig. 9c. In another embodiment, the sealing member 215 is coupled to an inner surface of the proximal portion 202c. It should be understood that the sealing member 215 may alternatively be coupled to an inner surface of the distal portion 202d or both the proximal portion 202c and the distal portion 202d of the frame 202. The sealing member 215 is coupled to the frame 202 using a technique, such as, stitching, adhesive bonding, welding, etc. In an embodiment, the sealing member 215 is stitched (or sutured) to the frame 202 using sutures of a desired material (e.g., polypropylene) in a desired pattern (e.g., 1:1). The sealing member 215 may be made of biocompatible material, such as, without limitation, polyester, thermoplastic polyurethane (TPU). In an embodiment, the sealing member 215 is made of polyester.
[0093] In an embodiment, the proximal end of each filament 204 of the frame 202 is coupled (e.g., fixedly coupled) to the distal end 224b of the tube 224 and the distal end of each filament 204 of the frame 202 is coupled (e.g., fixedly coupled) to the distal end 222b of the rod 222. In an embodiment, the plug 200 includes a proximal jacket 200c and a distal jacket 200d coupled to the frame 202 at the proximal end 200a and the distal end 200b of the plug 200, respectively. The proximal jacket 200c is configured to couple the proximal end 202a of the frame 202 and the distal end 224b of the tube 224. The distal jacket 200d is configured to couple the distal end 202b of the frame 202 to the distal end 222b of the tube 224. In an embodiment, the proximal jacket 200c is generally cylindrical and includes a first aperture (not shown) extending from its distal end towards its proximal end at least for a partial length of the proximal jacket 200c. Similarly, the distal jacket 200d is generally cylindrical and includes a second aperture (not shown) extending from its proximal end towards its distal end at least for a partial length of the distal jacket 200d. The filaments 204 may be coupled to the proximal jacket 200c and the distal jacket 200d using techniques, such as, without limitation, welding, UV bonding, jacket crimping, etc. In an embodiment, the proximal end of each filament 204 is disposed in the first aperture of the proximal jacket 200c and is welded to an inner surface of the proximal jacket 200c. Similarly, in an embodiment, the distal end of each filament 204 is disposed in the second aperture of the distal jacket 200d and is welded to an inner surface of the distal jacket 200d at the proximal end 200a and the distal end 200b, respectively.
[0094] The proximal jacket 200c and the distal jacket 200d are coupled to the distal end 224b of the tube 224 and the distal end 222b of the rod 222, respectively. The proximal jacket 200c and the distal jacket 200d may be coupled to the tube 224 and the rod 222, respectively, using techniques, such as, without limitation, welding, threaded coupling, UV bonding, heat shrink (using sleeve), etc. In an embodiment, the proximal jacket 200c is welded to distal end of the tube 224 such that the proximal end of the filaments 204 are disposed between the outer surface of the tube 224 and the inner surface of the proximal jacket 200c. Similarly, the distal jacket 200d is welded to distal end of the tube 224 such that the distal end of the filaments 204 are disposed between the outer surface of the tube 224 and the inner surface of the distal jacket 200d.
[0095] In an embodiment, the actuation assembly 220 is configured to toggle the plug 200 between the deployed state and the undeployed state. The actuation assembly 220 is configured to deploy the plug 200 in the vessel. In an embodiment, when the actuation assembly 220 is unactuated, i.e., in an unactuated state of the actuation assembly 220, the plug 200 (and the frame 202) is in the undeployed state. In the undeployed state, the plug 200 (and the frame 202) is seated within a first lumen 126c of the first punching element 126. In the undeployed state, the protrusion 222c of the rod 222 is disposed at the first position within the longitudinal slot 224c (specifically, in the distal groove Y of the longitudinal slot 224c) on the tube 224. Further, the distal end 202b of the frame 202 is positioned distally from the proximal end 202a of the frame 202 at a first pre-defined distance. The proximal end 202a and the distal end 202b of the frame 202 are similarly spaced apart by the first pre-defined distance. The proximal end 202a and the distal end 202b of the frame 202 are coupled to the distal end 224b of the tube 224 and the distal end 222b of the rod 222, respectively.
[0096] In an embodiment, the plug 200 is toggled between the closed state and the open state using the rod 222. In response to receipt of a first trigger by the actuation assembly 220, the plug 200 (and the frame 202) is configured to toggle from the undeployed state to the deployed state. In the deployed state, the protrusion 222c of the rod 222 is disposed at of the second position within the longitudinal slot 224c (specifically, in the proximal groove X) on the tube 224. For example, the first trigger includes moving the rod 222 in the proximal direction, i.e., moving the protrusion 222c from the first position to the second position on the longitudinal slot 224c (i.e., from the distal groove Y to the proximal groove X of the longitudinal slot 224c). The proximal movement of the rod 222 causes the distal end 222b of the rod 222 to move proximally towards the distal end 224b of the tube 224 and the distal end 202b of the frame 202 to move towards the proximal end 202a of the frame 202. Consequently, the frame 202 expands to form a cup-like shape. The plug 200 and the frame 202 are, thus, in the deployed state. Further, in the expanded/deployed state, the distal end 202b of the frame 202 is positioned distally at a second pre-defined distance from the proximal end 202a of the frame 202. The second pre-defined distance is smaller than the first pre-defined distance. Thus, in the actuated state of the actuation assembly 220, the plug 200 is in the expanded configuration. The first pre-defined distance and the second predefined distance are chosen depending upon the target vessel. For example, if the device 100 is being used for the aorta, the first pre-defined distance and the second predefined distance may range between 15 mm and 20 mm, and 0.1 mm and 1 mm, respectively.
[0097] In response to receipt of a second trigger by the actuation assembly 220, the plug 200 is configured to toggle from the deployed state to the undeployed state. For example, the second trigger includes moving the rod 222 in the distal direction, e.g., moving the protrusion 222c from second position to the first position on the longitudinal slot 224c (i.e., from the proximal groove X to the distal groove Y of the longitudinal slot 224c), causing the rod 222 to move in the distal direction. The distal movement of the rod 222 causes the distal end 222b of the rod 222 to move distally away from the distal end 224b of the tube 224 and the distal end 202b of the frame 202 to move away from the proximal end 202a of the frame 202. Consequently, the frame 202 collapses to form an ellipsoid-shape. The plug 200 and the frame 202 are, thus, in the deployed state.
[0098] Optionally, the plugging assembly includes two or more anchoring elements 206 (hereinafter, anchoring elements 206) and two or more anchoring strings 208 (hereinafter, anchoring strings 208). The anchoring elements 206 are provided circumferentially on the tube 224. In an embodiment, the plugging assembly includes two anchoring elements 206 and two anchoring strings 208. The anchoring elements 206 are configured to anchor the plug 200 with the vascular tissue. In an embodiment, each anchoring element 206 includes a proximal end 206a and a distal end 206b. The proximal end 206a of each anchoring element 206 is coupled to the tube 224 towards the distal end 224b. In an embodiment, the anchoring elements 206 are integrally coupled to the tube 224, i.e., the anchoring elements 206 and the tube 224 form an integrated structure. For example, the anchoring elements 206 may be laser-cut from the tube 224, forming respective grooves 206d (as shown in Fig. 9a) to receive the anchoring elements 206. In another embodiment, the anchoring elements 206 and the tube 224 may be separate components coupled together using any suitable technique. The anchoring elements 206 are provided on the tube 224 diametrically opposite to each other towards the distal end 224b of the tube 224.
[0099] The anchoring strings 208 are coupled to the frame 202. Further, each anchoring string 208 is coupled to a corresponding anchoring element 206. For example, a proximal end 208a of each anchoring string 208 is coupled to the distal end 206b of the corresponding anchoring element 206. In an embodiment, the anchoring strings 208 are welded to the anchoring elements 206, though any other suitable coupling technique may also be used to achieve the coupling. In another embodiment, the distal end 206b of the anchoring elements 206 are stitched to the anchoring strings 208 using, for example, polypropylene sutures. A distal end (not shown) of each anchoring string 208 is coupled to the proximal end 200a of the plug 200 (and, the frame 202). The anchoring strings 208 may be coupled to the proximal end 202a of the frame 202 using techniques, such as, without limitation, stitching, knotting, hooking, bonding, etc. In an embodiment, the anchoring strings 208 are stitched to the frame 202.
[00100] The anchoring elements 206 may be made of a material, such as, without limitation, nitinol, stainless steel, etc. In an embodiment, the anchoring elements 206 are made of nitinol. In an embodiment, the anchoring strings 208 are made of polypropylene, though they may be made of any other suitable materials.
[00101] The anchoring elements 206 are configurable between a stowed state and an unfurled state. Further, the anchoring strings 208 are configurable between a slack state and the taut state. When the anchoring elements 206 are in the stowed state or the unfurled state, the anchoring strings 208 are in the slack state or the taut state, respectively. In response to the movement of the anchoring elements 206 from the stowed state to the unfurled state, the anchoring strings 208 are configured to toggle from the slack state to the taut state, and vice versa.
[00102] In the stowed state, the anchoring elements 206 align with a longitudinal axis of the tube 224. When the anchoring elements 206 are disposed in the punching assembly 120, specifically within the first lumen 126c, the anchoring elements 206 are in the stowed state, due to the constraining for applied by the first punching element 126.
[00103] The anchoring elements 206 are biased to be in the unfurled state. In response to the separation of the punching assembly 120 from the actuation assembly 220, the anchoring elements 206 are configured to unfurl from the stowed state. In the unfurled state, the distal end 206b of each anchoring element 206 are disposed radially away from the longitudinal axis of the tube 224. In response to the anchoring elements 206 being unfurled, the anchoring strings 208 are configured to move to the taut state from the slack state.
[00104] Fig. 10 depicts a flowchart of an exemplary method 1000 to use the device 100 of the present disclosure to create a puncture and an anastomosis in a vessel 500. The method 1000 commences at step 1002 by creating a cut (incision) at a treatment site, for example, a vasculature tissue, using a surgical device, e.g., scalpel, lancet, etc.
[00105] At step 1004, the rim 126d of the first punching element 126 is inserted into the vessel 500 such that a proximal face of the rim 126d contacts an inner surface of the vessel 500 at the target site, as shown in Fig. 11a. At this step, the actuation assembly 220 is in the unactuated state and the plug 200 is disposed/seated within the first lumen 126c in the undeployed state, as shown in Fig. 11b.
[00106] At step 1006, the plug 200 is deployed at the target site. In an embodiment, the plug 200 is exposed within the vessel 500 at the target site as shown in Fig. 12a. To expose the plug 200, the locking member 228 is pushed in a distal direction until the distal end 224b of the tube 224 protrudes out of the distal end 126b of first punching element 126. The protrusion 222c of the rod 222 remains locked in the first position (i.e., the protrusion 222c is disposed at the distal groove Y) of the tube 224 and the plug 200 is in the undeployed state.
[00107] Thereafter, the plug 200 is set to the deployed state. In an embodiment, to set the plug 200 in the deployed state, the locking member 228 is rotated in a first direction (e.g., a clockwise direction) to unlock the protrusion 222c from the first position (i.e., the distal groove Y). The rod 222 is then moved in the proximal direction, e.g., by pulling either the rod 222 or the locking member 228 in the proximal direction. This causes the protrusion 222c to slide within the longitudinal slot 224c of the tube 224 from the distal end of the longitudinal slot 224c towards the proximal end of the longitudinal slot 224c. Further, the distal end 222b of the rod 222 moves towards the distal end 224b of the tube 224. This causes the distal jacket 200d to move towards the proximal jacket 200c, thereby expanding the frame 202 of the plug 200. The rod 222 is moved until the protrusion 222c is disposed at the second position within the longitudinal slot 224c and the frame 202 fully expands to the deployed state, as shown in Fig. 12b. The plug 200 surrounds the target site as depicted. The locking member 228 is then rotated in a second direction (e.g., anticlockwise direction) such that the protrusion 222c is disposed in the second position (i.e., the proximal groove X) as depicted in Fig. 12c. This locks the position of the rod 222 with respect to the tube 224.
[00108] At step 1008, the plunger 124 is actuated to create a puncture at the treatment site. In an embodiment, the plunger 124 is actuated by pushing the annular flange 124d of the plunger 124 towards the distal end 100b. When the plunger 124 is pushed, the second punching element 128 moves along the plunger 124 towards the distal end 100b. As explained earlier, the vascular wall is sandwiched between the rim 126d of the first punching element 126 and the distal end 128b of the second punching element 128. Force applied by the second punching element 128 results in the distal end 128b of the second punching element 128 penetrate the vessel wall, contact the proximal face of the rim 126d (as shown in Fig. 13) and move past the distal end 126b of the first punching element 126 (such that the first punching element 126 is disposed within the second punching element 128), thereby creating a puncture at the treatment site. The puncture created is sealed by the plug 200, specifically by the sealing member 215, such that no blood leaks through the puncture.
[00109] At step 1010, the handle 122 is retracted in the proximal direction while holding the plugging assembly at the same position to configure the anchoring elements 206 in the unfurled state. As the handle 122 retracts, the anchoring elements 206 are exposed out of the first punching element 126. Without any constraining force, the anchoring elements 206 toggle to the unfurled state as shown in Fig. 9a. Consequently, the anchoring strings 208 are configured in the taut state. As explained earlier, the anchoring elements 206 and the anchoring strings 208 help in holding the plug 200 at the target site.
[00110] At step 1012, the locking member 228 is decoupled from the rod 222, for example, by disengaging the internal threads of the locking member 228 and the external threads of the rod 222, as shown in Fig. 14a.
[00111] At step 1014, the punching assembly 120 is decoupled from the plugging assembly such that only the plugging assembly remains at the treatment site as depicted in Fig. 14b.
[00112] At step 1016, the medical practitioner partially sutures the puncture.
[00113] At step 1018, the plug 200 is set to the undeployed state. In an embodiment, the rod 222 is rotated in the first direction to unlock the protrusion 222c from second position (i.e., the proximal groove X) and pushed in the distal direction towards the distal end of the longitudinal slot 224c. This movement causes the plug 200 to switch to the undeployed state as explained earlier. The rod 222 is then rotated in the second direction to lock the protrusion 222c in the first position (i.e., the distal groove Y).
[00114] At step 1020, the actuation assembly 220 is withdrawn from the treatment site and the puncture site is fully sutured to create an anastomosis.
[00115] 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 teaching of the present invention is/are used.
, C , Claims:We claim
1. An anastomosis device (100) comprising:
a. a plunger (124) comprising a plunger lumen (124c);
b. a first punching element (126) partially disposed within the plunger lumen (124c);
c. a second punching element (128) coupled to the plunger (124) and slidably disposed over first punching element (126);
d. a plug (200) configured to toggle between an undeployed state and a deployed state, wherein in the undeployed state, the plug (200) is seated within a first lumen (126c) of the first punching element (126); and
e. an actuation assembly (220) coupled to the plug (200) and configured to deploy the plug (200) in a vessel
f. wherein the first punching element (126) and the second punching element (128) are configured to create a puncture in the vessel
g. wherein, in a deployed state, the plug (200) is configured to occlude the puncture.
2. The device (100) as claimed in claim 1, wherein the plug (200) comprises a frame (202) having a proximal end (202a) and a distal end (202b) coupled to the actuation assembly (220); wherein, in the undeployed state, the frame (202) in a collapsed configuration and in the deployed state, the frame (202) is in an expanded configuration.
3. The anastomosis device (100) as claimed in claim 2, wherein the actuation assembly (220) comprises:
a. a tube (224) partially disposed within the plunger lumen (124c) and a first lumen (126c) of the first punching element (126), and coupled to the proximal end (202a) of the frame (202); and
b. a rod (222) slidably disposed within the tube (224) and coupled to the distal end (202b) of the frame (202).
4. The anastomosis device (100) as claimed in claim 3, wherein:
a. the tube (224) comprises a longitudinal slot (224c); and
b. the rod (222) comprises a protrusion (222c) slidably disposed within the longitudinal slot (224c) of the tube (224) and movable between a first position and a second position on the longitudinal slot (224c);
wherein, in the undeployed state, the protrusion (222c) of the rod (222) is disposed at the first position of the longitudinal slot (224c), and
wherein, in the deployed state, the protrusion (222c) of the rod (222) is disposed at the second position of the longitudinal slot (224c).
5. The anastomosis device (100) as claimed in claim 4, wherein the longitudinal slot (224c) comprises:
a. a proximal groove (X) provided at the second position of the longitudinal slot (224c); and
b. a distal groove (Y) provided at the first position of the longitudinal slot (224c);
wherein, the proximal groove (X) and the distal groove (Y) are configured to receive the protrusion (222c) of the rod (222) and lock the protrusion (222c) at a respective position.
6. The device (100) as claimed in claim 3, wherein the actuation assembly (220) comprises a locking member (228) removably coupled to a proximal end (222a) of the rod (222).
7. The anastomosis device (100) as claimed in claim 3, wherein the plug (200) comprises:
a. a proximal jacket (200c) configured to couple the proximal end (202a) of the frame (202) and the distal end (224b) of the tube (224); and
b. a distal jacket (200d) configured to couple the distal end (202b) of the frame (202) and the distal end (222b) of the rod (222).
8. The device (100) as claimed in claim 3, wherein the device (100) comprises:
a. two or more anchoring elements (206) configured to toggle between a stowed state and an unfurled state, each anchoring element (206) having a proximal end (206a) coupled to the tube (224) towards the distal end (224b) of the tube (224); and
b. two or more anchoring strings (208), each anchoring string (208) having a proximal end (208a) coupled to a distal end (206b) of a corresponding anchoring element (206) and a distal end coupled to the frame (202);
wherein, in the stowed state, the two or more anchoring elements (206) are aligned with a longitudinal axis of the tube (224);
wherein, in the unfurled state, distal end (206b) of the two or more anchoring elements (206) are disposed radially away from the longitudinal axis of the tube (224).
9. The anastomosis device (100) as claimed in claim 2, wherein in the undeployed state, the distal end (202b) of the frame (202) is positioned distally from the proximal end (202a) of the frame (202) by a first pre-defined distance; and wherein, in the deployed state, the distal end (202b) of the frame (202) is positioned distally from the proximal end (202a) of the frame (202) by a second pre-defined distance, wherein the second pre-defined distance is smaller than the first pre-defined distance.
10. The anastomosis device (100) as claimed in claim 2, wherein the frame (202) comprises a plurality of filaments (204) braided in a predefined pattern.
11. The anastomosis device (100) as claimed in claim 2, wherein:
a. the frame (202) comprises a proximal portion (202c), a distal portion (202d) and a transition boundary (T) therebetween;
b. wherein, in the deployed state, the proximal portion (202c) is disposed inside the distal portion (202d).
12. The anastomosis device (100) as claimed in claim 2, wherein the plug (200) comprises a sealing member (215) disposed within the frame (202) and coupled to the frame (202), the sealing member (215) configured to seal the puncture.
13. The device (100) as claimed in claim 1, wherein the first punching element (126) comprises at least one hole (126f) and the plunger (124) comprises at least one elongated hole (124f) at least partially aligned with the at least one hole (126f) of the first punching element (126), wherein the device (100) comprises:
a. a handle (122) comprising a handle lumen (122c) configured to receive the plunger (124) and at least one hole (122f) aligned with the at least one hole (126f) of the first punching element (126); and
b. a locking pin (180) disposed within the at least one hole (122f) of the handle (122), the at least one hole (126f) of the first punching element (126) and the at least one elongated hole (124f) of the plunger (124), the locking pin (180) configured to prevent relative movement between the handle (122) and the first punching element (126).
14. The anastomosis device (100) as claimed in claim 1, wherein the first punching element (126) comprises:
a. a proximal portion (126a1) provided at a proximal end (126a) of the first punching element (126);
b. a distal portion (126b1) provided at a distal end (126b) of the first punching element (126) and disposed outside the plunger lumen (124c); and
c. a middle portion (126a2) disposed between the proximal portion (126a1) and the distal portion (126b1);
wherein the second punching element (128) is disposed over the middle portion (126a2).
15. The anastomosis device (100) as claimed in claim 14, wherein the plunger lumen (124c) comprises:
a. a first section (A) disposed towards a proximal end (124a) of the plunger (124);
b. a second section (B) disposed towards a distal end (124b) of the plunger (124) and configured to receive the second punching element (128) such that the second punching element (128) is disposed between an outer surface of the middle portion (126a2) of the first punching element (126) and an inner surface of the second section (B) of the plunger lumen (124c); and
c. a third section (C) disposed between the first section (A) and the second section (B), and configured to receive the proximal portion (126a1) and a proximal section of the middle portion (126a2) of the first punching element (126);
wherein a diameter of the first section (A) is smaller than a diameter of the third section (C), defining a first flange (124c1);
wherein the diameter of the third section (C) is smaller than a diameter of the second section (B), defining a second flange (124c2) coupled with a proximal face of the second punching element (128);
in response to the actuation of the plunger (124), the second punching element (128) is configured to move in a distal direction.
16. The anastomosis device (100) as claimed in claim 15, wherein the anastomosis device (100) comprises:
a. a bush (130) disposed within the third section (C) of the plunger lumen (124c), and comprising:
i. a head (130d) provided at a distal end (130b) and abutting a proximal face of the first punching element (126);
ii. a body (130e) extending from the head (130d) to a proximal end (130a) of the bush (130); and
b. at least one resilient element (134) wrapped around the body (130e) of the bush (130) and extending between the first flange (124c1) and a proximal face of the head (130d);
wherein, upon actuation of the plunger (124), the at least one resilient element (134) is configured to provide resilience to the plunger (124) to return the plunger (124) to an initial position.
17. The anastomosis device (100) as claimed in claim 1, wherein the first punching element (126) comprises a rim (126d) provided at a distal end (126b) of the first punching element (126) and disposed outside the plunger lumen (124c), the rim (126d) is configured to reside in a vessel.
18. The anastomosis device (100) as claimed in claim 1, wherein in response to actuation of the plunger (124), the second punching element (128) is configured to slide over the first punching element (128) in a distal direction.
19. The anastomosis device (100) as claimed in claim 1, wherein the second punching element (128) comprises a tapered portion (128d) provided at a distal end (128b) of the second punching element (128).