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

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

 
FIELD OF INVENTION
[001] The present invention relates to a medical device. More specifically, the present invention relates to an anastomosis device.
BACKGROUND OF INVENTION
[002] Vascular anastomosis is a procedure of connecting two vessels such as arteries or veins, to restore blood flow. The connection may be established through a surgical procedure where the vessels are manually sutured, or via an endovascular procedure.
[003] During an endovascular procedure, a graft (or an anastomosis device) is used to establish a connection between two vessels. The anastomosis device is placed between the vessels which are to be connected and the anastomosis device connects the two vessels thereby forming an anastomosis between the two vessels. Due to high rates of blood flow and the pressure within the blood vessels, the conventionally known devices are prone to migration from the site of deployment, which can lead to obstruction in the vasculature causing embolization or improper vessel connection. Additionally, improper sealing, may cause blood leakage at the anastomotic site, resulting in complications such as hematoma, pseudoaneurysm, and hemorrhage. These conditions can impair circulation, exert pressure on surrounding structures, and, in severe cases, lead to hypovolemic shock or ischemic damage.
[004] Therefore, there arises a need of an anastomosis device that overcomes the problems associated with conventional anastomosis devices.
SUMMARY OF INVENTION
[005] The present invention relates to an anastomosis device including, a resilient member and a support member. The resilient member is braided from multiple filaments. The resilient member includes a canopy disposed towards a distal end of the device, and a shaft extending from the canopy and disposed towards a proximal end of the device. The shaft includes a channel extending from the proximal end to the distal end of the device. The support member is disposed coaxially within the shaft of the resilient member.
[006] 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
[007] 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.
[008] Fig. 1 depicts an anastomosis device 100 (or device 100) deployed between a first blood vessel 10 and a second blood vessel 20, in accordance with an embodiment of the present disclosure.
[009] Fig. 2 depicts a side view of the device 100, in accordance with an embodiment of the present disclosure.
[0010] Fig. 3 depicts a side view of a resilient member 110 of the device 100, in accordance with an embodiment of the present disclosure.
[0011] Fig. 4 depicts a cross-sectional view of the device 100, in accordance with an embodiment of the present disclosure.
[0012] Fig. 5 depicts a top perspective view of a resilient member 110 of the device 100, in accordance with an embodiment of the present disclosure.
[0013] Fig. 6 depicts a perspective view of a support member 130 of the device 100, in accordance with an embodiment of the present disclosure.
[0014] Fig. 7 depicts a crimped state of the device 100, in accordance with an embodiment of the present disclosure.
[0015] Fig. 8 depicts a delivery system 200 used to deploy the device 100, in accordance with an embodiment of the present disclosure.
[0016] Fig. 9 depicts the device 100 mounted on an inner tube 250 of the delivery system 200, in accordance with an embodiment of the present disclosure.
[0017] Fig. 10 depicts a method 1000 of deploying the device 100 using the delivery system 200, in accordance with an embodiment of the present disclosure.
[0018] Fig. 11 depicts the device 100 mounted on the delivery system 200 in its crimped state, in accordance with an embodiment of the present disclosure.
[0019] Fig. 12 depicts the deployed state of the device 100 between the first blood vessel 10 and the second blood vessel 20, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0020] 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.
[0021] 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.
[0022] 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.
[0023] 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.
[0024] In accordance with the present disclosure, an anastomosis device (or device) for vascular anastomosis is disclosed. The device is deployed between two blood vessels to create an anastomosis. The device can be deployed by using a minimally invasive procedure through the vasculature(s) of a patient. The device of the present invention includes a resilient member and a support member. The support member is disposed within the resilient member. The resilient member is formed by braiding a plurality of filaments. The filaments define an umbrella like shape having a canopy and a shaft. The filaments of the braided member are braided in such a way that the density of the filaments is higher at the center compared to the edges of the resilient member. This in turn, reduces the chances of blood leakage from the anastomosis site between the two vessels. The support member may be laser cut from a metallic tube. In an embodiment, the support member is provided with a plurality of spikes to grip the wall of the blood vessels that reduces the chances of migration of the device from the deployment site.
[0025] Now referring to figures, Fig. 1 depicts an exemplary anastomosis device 100 (or device 100) of the present disclosure deployed between a first blood vessel 10 and a second blood vessel 20. In the depicted embodiment, the first blood vessel 10 and the second blood vessel 20 are positioned substantially perpendicular to each other. However, the two may be at any angle with each other depending upon the angle required at a deployment site. In an embodiment, the device 100 creates an anastomosis between the first blood vessel 10 and the second blood vessel 20. The device 100 creates a fluidic connection between the first blood vessel 10 and the second blood vessel 20 thereby allowing the blood to flow from the first blood vessel 10 to the second blood vessel 20 or vice-versa. In an embodiment, a portion of the device 100 is disposed within the first blood vessel 10 and another portion of the device 100 is disposed within the second blood vessel 20. The deployment and positioning of the device 100 within the first blood vessels 10 and the second blood vessel 20 is explained in detail later.
[0026] Now referring to Fig. 2, the device 100 in accordance with an embodiment of the present disclosure is depicted. The device 100 includes a proximal end 100a and a distal end 100b. The device 100 has a deployed state as depicted in Fig. 2 and a crimped state (depicted in Fig. 6). The device 100 can be toggled from the crimped state to the deployed state during deployment (explained in detail later). In the deployed state, the device 100 unfurls like an umbrella. That is, the device 100 translates into a circular canopy having a tubular shaft towards the center.
[0027] In an embodiment, the device 100 includes a resilient member 110 and a support member 130. The support member 130 is disposed within the resilient member 110 towards the proximal end 100a of the device 100.
[0028] Now moving on to Fig. 3, a side view of the device 100 is depicted. In an embodiment, the resilient member 110 defines the umbrella like structure of the device 100. The resilient member 110 includes at least a canopy 111 and a shaft 113. The canopy 111 is disposed towards the distal end 100b of the device 100. The canopy 111 is configured to grip an inner wall of the first blood vessel 10. The shaft 113 is disposed towards the proximal end 100a of the device 100. The shaft 113 is configured to be positioned against an inner wall of the second blood vessel 20.
[0029] The resilient member 110 is made by braiding multiple filaments 170. The filaments 170 may be made of a biocompatible material including but not limited to nitinol, stainless steel, etc. In an embodiment, the filaments 170 are made of nitinol. The filaments 170 may have a pre-defined diameter. The diameter of the filaments 170 may range between 1.7mm to 1.8mm. In an embodiment, the diameter of the filaments 170 is 1.7mm. The filaments 170 may be coated with a layer of predefined material. The layer provides a smooth surface to the filaments 170, allowing the blood to flow smoothly over the surface of the filaments 170 thereby, reducing the chances of thrombus formation. The material may include without limitation polytetrafluoroethylene (PTFE), polyurethane (PU), pericardium, dextran, silicon, etc. In an embodiment, the filaments 170 are coated with silicon.
[0030] Referring to Fig. 4, each filament 170 has two ends – a first end 170a and a second end 170b. Starting from the proximal end 100a, the first end 170a of the filament 170 extends along the central axis of the device 100 defining the shaft 113. Thereafter, at the distal end 100b, the filament 170 forms a loop (or fold) defining the canopy 111. The filament 170 is arranged radially around the central axis forming the canopy 111. Then, the filament 170 runs straight from the canopy 111 back to the proximal end 100a of the device 100, where the second end 170b is then stationed. Thus, each filament 170 traverses a path from the proximal end 100a and returns to the proximal end 100a after defining the shaft 113 and the canopy 111. The first end 170a and the second end 170b of filament 170 may be in close proximity post the foregoing arrangement.
[0031] In an embodiment, each filament 170 that traverses the aforesaid path from the proximal end 100a and returns to the proximal end 100a after defining the shaft 113 and the canopy 111, is jointless. The jointless structure of the filament 170 allows even distribution of the stress through the length of the filament. The even distribution of the stress reduces the chances of breakage of the filament 170 during and/or post the deployment of the device 100. Thus, increasing the longevity of the device 100. Alternately, various segments of filaments 170 may be joined to form a single filament 170.
[0032] Once all the filaments 170 are placed as described, they form two layers - an outer layer and an inner layer. The two layers are joined at the fold provided at the outer edge 111c of the canopy 111. Both the outer layer and the inner layer of filaments 170 of the shaft 113 are concentric. In an embodiment, the first ends 170a of the filaments 170 refer to ends of the outer layer. While, the seconds ends 170b of the filaments 170 refer to the ends of the inner layer.
[0033] The first end 170a and the second end 170b of each filament 170 may be coupled to respective first or second ends of adjacent filaments 170. For example, each second end of the inner layer may be coupled to the adjacent second ends of the inner layer and each first end of the outer layer may be coupled to the adjacent first ends of the outer layer. The filaments 170 may be coupled using a coupling method such as, laser welding, arc welding, adhesives, etc. In an embodiment, the filaments 170 are coupled using adhesives.
[0034] In an embodiment, the filaments 170 of the outer layer of the canopy are curved while the filaments 170 of the inner layer of the canopy are substantially straight. The inner layer of the filaments 170 extending beyond the canopy 111, define a channel 117 along the central axis of the device 100. The channel 117 extends from the proximal end 100a to the distal end 100b of the device 100. The channel 117 is configured to allow the blood to flow from the first blood vessel 10 to the second blood vessel 20 or vice-versa.
[0035] In an embodiment, the channel 117 has a tubular shape though, the channel 117 may have any other shape. The channel 117 defines a central passage, configured to allow the blood to flow through. The diameter of the channel 117 may range between 1.50mm to 1.95mm. In an embodiment, the diameter of the channel 117 is1.55mm.
[0036] The number of the filaments 170 in the resilient member 110 may depend upon the size of the support member 130. The number of the filaments 170 may range between 25 and 50. In an embodiment, the number of filaments 170 is 50.
[0037] In an embodiment, as shown in Fig. 5, the braiding density of the filaments 170 increases from the outer edge 111c of the canopy 111 to the channel 117 i.e., the filaments 170 are placed closer to each other towards the channel 117 compared to the outer edge 111c. The higher braiding density of the filaments 170 at the center of the canopy 111 reduces the chances of leakage of the blood from the point of anastomosis between the first blood vessel 10 and the second blood vessel 20.
[0038] The braiding density of the shaft 113 may be higher with respect to the braiding density of the outer edge 111c of the canopy 111. The higher braiding density of the shaft 113 provides a leakproof passage of the blood between the first blood vessel 10 and the second blood vessel 20.
[0039] The shaft 113 may have a predefined length and diameter. The length and the diameter of the shaft 113 may be determined on the basis of the structure of the second blood vessel 20. In an embodiment, the diameter of the shaft 113 corresponds to an inner diameter of the second blood vessel 20. The diameter of the shaft 113 ranges between 4mm and 5mm. In an embodiment, the diameter of the shaft 113 is 5mm.
[0040] In an embodiment, the canopy 111 has a top face 111a and a bottom face 111b. The bottom face 111b of the canopy 111 mates with the inner wall of the first blood vessel 10. In an embodiment, the canopy 111 is inclined towards the shaft 113. That is, the outer edge 111c of the canopy 111 is bent towards the central axis of the device 100 compared to the portion around the channel 117. The bent in the canopy 111 facilitates firm grip of the device 100 on the inner wall of the first blood vessel 10 thereby, reducing the chances of unintended movement of the canopy 111 of the resilient member 110 in the first blood vessel 10. Reducing unintended movement of the canopy 111 reduces the chances of damage to the neighboring tissues of the inner wall of the first blood vessel 10.
[0041] Further, the outer layer and inner layer of the resilient member 110, define an annular gap. The annular gap is configured to hold the support member 130 within the shaft 113 of the resilient member 110. In an embodiment, the support member 130 is placed coaxially within the shaft 113. The support member 130 is completely disposed within the annular gap between the outer layer and the inner layer of filaments 170 of the shaft 113. Thus, providing a composite structure to the shaft 113. The composite structure of the shaft 113 includes multiple layers. For example, two braided layers (i.e., the inner layer and the outer layer) and a metallic layer of support member 130 between the two braided layers.
[0042] The first end 170a and the second end 170b of the filaments 170of the resilient member 110 may extend beyond the support member 130 towards the proximal end 100a of the device 100. Alternatively, the first end 170a and the second end 170b of the filaments 170 of the resilient member 110 may align with a proximal end of the support member 130. In an embodiment, the first end 170a and the second end 170b of the filaments 170 of the resilient member 110 extend beyond the support member 130. Due to which, the support member 130 remains completely enclosed between the outer layer and the inner layer of resilient members 110. Such arrangement of the support member 130 within the resilient member 110, minimizing the chances of disengagement of the support member 130 from the resilient member 110 during and post-deployment of the device 100.
[0043] Now, the structure of the support member 130 is explained in reference to Fig. 6. The support member 130 provides structural strength to the shaft 113 of the resilient member 110 and diminishes the chances of collapse of the shaft 113 due to pressure exerted by the second blood vessel 20 on the shaft 113 of the resilient member 110. The support member 130 may be laser cut from a metallic tube. The support member 130 may be made of a biocompatible material including, but not limited to copper, manganese, stainless steel, and combination thereof. In an embodiment, the support member 130 is made from manganin, an alloy of copper, manganese and nickel.
[0044] The support member 130 has a proximal end 130a and a distal end 130b. The support member 130 has a tubular structure with a hollow interior. The support member 130 includes a plurality of components including but not limited to a top portion 131, a bottom portion 133, and a body 135.
[0045] The top portion 131 is disposed towards the proximal end 130a of the support member 130. In an embodiment, the top portion 131 has a circular rim though, the rim of the top portion 131 may have any other shape such as, without limitation, ovel, pentagon, hexagon, etc. The top portion 131 may have a predefined outer diameter ranging from 1.40mm to 1.56mm. In an embodiment, the outer diameter of the top portion 131 is 1.55mm. The inner diameter of the top portion 131 corresponds to the diameter of channel 117 of the resilient member 110.
[0046] The bottom portion 133 is disposed towards the distal end 130b of the support member 130. The structure and function of the bottom portion 133 is same as that of the top portion 131, hence, may be referred from the description above and is not repeated for the sake of brevity.
[0047] The body 135 of the support member 130 is disposed between the top portion 131 and the bottom portion 133. An outer surface of the body 135 of the support member 130 sits against the outer layer of the shaft 113 (as shown in Fig. 4). In an embodiment, the body 135 of the support member 130 has a curved cylindrical shape though, the body 135 may have any other suitable shape. The body 135 of the support member 130 tapers inwards towards the top portion 131 and the bottom portion 133. The body 135 of the support member 130 has a hollow interior. At least a portion of the channel 117 is disposed within the interior of the body 135.
[0048] The body 135 of the support member 130 includes a plurality of cutouts 136 extending along a length of the body 135. In an embodiment, the cutouts 136 have a rectangular shape though, the cutouts 136 may have any other shape such as, without limitation circle, rectangular with curved edges, etc. In an embodiment, three cutouts 136 are equally spaced around the surface of the support member 130 though any other arrangement of the cutouts 136 is within the scope of the present disclosure. The cutouts 136 reduce the weight of the support member 130. Further, the cutouts 136 may reduce the amount of material required for construction of the support member 130 thereby, reducing the overall cost of production of the device 100.
[0049] The body 135 of the support member 130 is provided with a plurality of spikes 134. The spikes 134 are configured to grip the inner wall of the second blood vessel 20. In an embodiment, the spikes 134 are triangular cutouts made on the outer surface of the body 135. The spikes 134 protrude outwards at a predefined angle from the body 135. The predefined angle may range between 0.70mm and 0.85mm. In an embodiment, the predefined angle is 0.80mm. In an embodiment, the spikes 134 are arranged in a row of three spikes 134 along the central axis of the support member 130. Each row of spikes 134 are disposed between two adjacently disposed cutouts 136. In an embodiment, in each row of the spikes 134, the spikes 134 are pointed towards the top portion 131. Alternatively, the spikes 134 may be pointed towards the bottom portion 133 (as shown in Fig. 2). Additionally, or optionally, the alternate rows of the spikes 134 may have alternate configurations of the spikes 134, i.e., one of the rows may have the spikes 134 pointed towards the bottom portion 133 and the adjacent row may have spikes 134 pointed towards the top portion 131. Any other arrangements of the spikes 134 are also within the scope of the present disclosure.
[0050] Once the support member 130 is disposed within the shaft 113 of the resilient member 110, the spikes 134 at least partially protrude through the outer layer of the shaft 113, exposing the tips of the spikes 134 out of the resilient member 110 (as shown in Fig. 4). The exposed tips of the spikes 134 allow the device 100 to grip hold an inner wall of the second blood vessel 20. The spikes 134 may at least partially penetrate through the wall of the second blood vessel 20 to fix the device 100 to the second blood vessel 20, thereby reducing the chances of migration of the device 100 from the second blood vessel 20. The positioning of the bottom face 111b of the resilient member 110 against the inner wall of first blood vessel 10 and the spikes 134 of the support member 130 fixed on the walls of the second blood vessel 20 result in a secure anastomosis between the first blood vessel 10 and the second blood vessel 20.
[0051] Fig. 7 depicts a crimped state of the device 100. In the crimped state, the canopy 111 remains in a substantially straight configuration. In the crimped state, the canopy 111 and the shaft 113 define a tubular structure of the device 100. The tubular structure of the device 100 allows the device 100 to be easily mounted on a delivery system. In the crimped state, the diameter of the canopy 111 is reduced. The reduced diameter of the canopy 111 allows easy navigation through the tortuous vasculature and deployment of the device 100.
[0052] The device 100 is deployed between the first blood vessel 10 and the second blood vessel 20 by using a delivery system through a minimally invasive procedure.
[0053] Referring to Fig. 8, a proximal portion of an exemplary delivery system 200 used to deploy the device 100 is depicted. The delivery system 200 includes a proximal end 200a and a distal end 200b. In an embodiment, the delivery system 200 includes a plurality of components such as, without limitation, an outer sheath 210, a first hub 230, an inner tube 250 and a second hub 270.
[0054] The outer sheath 210 has an elongated, tubular structure, defining a lumen. The outer sheath 210 is configured to allow the inner tube 250 to pass through it. The outer sheath 210 extends from the proximal end 200a of the delivery system 200 to the distal end 200b of the delivery system 200. The outer sheath 210 may be made from a biocompatible material including but not limited to, polycarbonate, acrylonitrile butadiene styrene (ABS), thermoplastic polyurethane (TPU) elastomers PEBAX, etc. In an embodiment, the outer sheath 210 is made from a combination of polycarbonate and ABS. The outer diameter and the inner diameter of the outer sheath 210 may be chosen based upon the clinical needs. In an embodiment, the outer diameter of the outer sheath 210 may range from 3.10mm to 3.20mm, and the inner diameter of the outer sheath 210 may range from 2.10mm to 2.20mm. In an exemplary embodiment, the outer sheath 210 has the outer diameter of 3.20mm and the inner diameter of 2.20mm. A proximal end of the outer sheath 210 is coupled to the first hub 230.
[0055] The first hub 230 is positioned towards the proximal end 200a of the delivery system 200. The first hub 230 has a tubular structure with a hollow interior. The hollow interior of the first hub 230 allows the inner tube 250 to pass through it. The first hub 230 may be made of a material including, but not limited to ABS, or polylactic Acid (PLA), etc. In an embodiment, the first hub 230 is made of ABS. In an embodiment, the first hub 230 is provided with a port 231, on one of its sides. The port 231 may be configured to allow water or sterile saline to flush out any debris or residual fluids to prevent clogging within the outer sheath 210.
[0056] The first hub 230 further includes a rotary knob 233 (or knob 233). In an embodiment, the knob 233 is configured to fix the position of the inner tube 250 within the outer sheath 210 thereby preventing any unintended relative motion of the inner tube 250 within the outer sheath 210. The knob 233 is rotated in a predefined direction to lock the position of the inner tube 250 within the outer sheath 210. The rotation of the knob 233 hold the inner tube 250 within the first hub 230. Further, the knob 233 may be rotated in an opposite direction to release the inner tube 250.
[0057] The first hub 230 includes a compression assembly coupled to the knob 233 and a sealing member (not shown). The compression assembly and the sealing member are disposed within the first hub 230 towards a proximal end of the first hub 230. The compression assembly includes a threaded screw rotatably coupled to the knob 233. In response to an anti-clockwise rotation of the knob 233, the screw compresses the sealing member radially over the inner tube 250. Thus, locking the position of the inner tube within the first hub 230. A clockwise rotation of the knob 233 releases the sealing member. Thus, unlocking the position of the inner tube 250.
[0058] The inner tube 250 extends from the proximal end 200a to the distal end 200b of the delivery system 200. The inner tube 250 is substantially disposed within the lumen of the outer sheath 210. In an embodiment, the inner tube 250 has an elongated cylindrical structure. Alternatively, the inner tube 250 may have a hollow tubular structure, configured to allow passage of a guidewire (not shown). The inner tube 250 may be made of a biocompatible material including but not limited to, polycarbonate and ABS, TPU elastomers, PEBAX etc. In an embodiment, the inner tube 250 is made of PEBAX. The diameter of the inner tube 250 may correspond to an inner diameter of the channel 117 of the device 100. In the embodiment, the diameter of the inner tube 250 ranges from 0.80mm to 0.85mm. In an embodiment, the diameter of the inner tube 250 is 0.85mm. Towards the proximal end 200a, the inner tube 250 is coupled to the second hub 270. The second hub 270 is positioned at the proximal end 200a of the delivery system 200. The second hub 270 is configured to allow a medical practitioner to control the relative motion of the inner tube 250 within the outer sheath 210.
[0059] The second hub 270 has an ergonomic shape to facilitate suitable grip on the second hub 270. In an embodiment, the second hub 270 is provided with threads 271. The threads may be used to couple the second hub 270 to a robotic system (not shown) to control the motion of the inner tube 250 within the outer sheath 210.
[0060] The inner tube 250 is provided with a plurality of stoppers 251 towards a distal end of the inner tube 250 (shown in Fig. 9). The stoppers 251 are positioned on the sides of the inner tube 250. In an embodiment, the inner tube 250 has two stoppers 251. Alternatively, the inner tube 250 may have more than two stoppers 251. The stoppers 251 are configured to hold the device 100 at a fixed position, towards the distal end of the inner tube 250. The stoppers 251 further prevent any unintended motion of the device 100 on the inner tube 250.
[0061] Now the procedure to deploy the device 100 will be described. In an embodiment, the deployment of the device 100 may be preceded by a pre-deployment procedure. In the pre-deployment procedure, a robotic surgical system (not shown) may be used to minimally invade from a suitable access point of a patient to the site of anastomosis e.g., in the proximity of the first blood vessel 10 and the second blood vessel 20. A robotic arm (or arm) of the robotic surgical system may make an incision on the first blood vessel 10 on one of the sides of the first blood vessel 10. Further, the arm may cut the second blood vessel 20 to create an open end. The open end of the second blood vessel 20 is positioned perpendicular to the side of the first blood vessel 10 on which the incision was made. Alternatively, the above procedure may be performed manually, by a medical practitioner. After the pre-deployment procedure, a method 1000 (depicted in Fig. 10) may be followed to deploy the device 100 between the first blood vessel 10 and the second blood vessel 20.
[0062] Fig. 10 depicts an exemplary method 1000 for deploying the device 100 using the delivery system 200.
[0063] At step 1001, the device 100 is mounted on the delivery system 200, thereby forming an assembly. The device 100 is mounted on the device 100 in the crimped state (as shown in Fig. 7). The device 100 is mounted on the inner tube 250 towards the distal end 200b of the delivery system 200 (as shown in Fig 11). The inner tube 250 is disposed at least partially within the channel 117 of the device 100. The stoppers 251 of the inner tube 250 may at least partially abuts the proximal end 100a of the device 100 and restrict the device 100 from sliding or moving from the distal end 200b towards the proximal end 200a. The inner tube 250 along with the device 100 are at least partially enclosed within the outer sheath 210.
[0064] At step 1002, the distal end 200b of the delivery system 200 along with the device 100 is inserted into a patient’s body via an appropriate vascular access point, e.g., through the transfemoral vein of the patient. In an exemplary embodiment, the delivery system 200 is inserted within the second blood vessel 20. Alternatively, a guidewire may first be inserted into the patient’s body and then, the inner tube 250 of the delivery system 200 is inserted over the guidewire and within the patient’s body. The knob 233 of the first hub 230 is rotated in the predefined direction to lock the position of the inner tube 250 within the outer sheath 210 at the beginning of navigation process. The inner tube 250 remains in the fixed position within the outer sheath 210, to avoid any unintended motion of the inner tube 250 within the outer sheath 210 throughout the navigation of the outer sheath 210.
[0065] At step 1003, the distal end 200b of the delivery system 200 is navigated and positioned at the target site e.g., at the site of anastomosis between the first blood vessel 10 and the second blood vessel 20. The outer sheath 210 is navigated to the end of the second blood vessel 20. In case the guidewire is inserted first, the outer sheath 210 is navigated over the guidewire to the site of anastomosis. The guidewire may be passed through the inner tube 250 to the site of anastomosis before advancing the delivery system 200 over the guidewire. The device 100, mounted on the inner tube 250, remains enclosed within the outer sheath 210 while the outer sheath 210 is navigated to the end of the second blood vessel 20.
[0066] At step 1004, the device 100 is deployed to create the anastomosis between the first blood vessel 10 and the second blood vessel 20. Once the outer sheath 210 reaches the open end of the second blood vessel 20, the outer sheath 210 is advanced from the open end of the second blood vessel 20 into the first blood vessel 10 via the incision made on the side of the first blood vessel 10 during the pre-deployment procedure. Once the distal end 200b of the outer sheath 210 is positioned within the first blood vessel 10 via the end of the second blood vessel 20, the knob 233 of the first hub 230 is rotated to release the inner tube 250.
[0067] The inner tube 250 is then carefully pushed towards the distal end 200b thereby exposing the device 100. The stoppers 251 facilitate the motion of the device 100 against an inner wall of the outer sheath 210. When the device 100 is exposed out of the outer sheath 210, the device 100 expands due to self-expanding property of the resilient member 110. The outer edge 111c of the canopy 111 of the resilient member 110, expands away from the central axis of the device 100. Further, the device 100 is deployed in such a way that the canopy 111 of the resilient member 110 remains within the first blood vessel 10 and the shaft 113 of the resilient member 110 remains in the second blood vessel 20 (as shown in Fig. 12). The bottom face 111b of the canopy 111 at least partially abuts the inner wall of the side of the first blood vessel 10. The spikes 134 of the support member 130 at least partially penetrate the wall of the second blood vessel 20. The spikes 134 and the canopy 111 fix the device 100 at least partially across the first blood vessel 10 and the second blood vessel 20 thereby creating the anastomosis therebetween.
[0068] At step 1005, the outer sheath 210 along with the inner tube 250 is withdrawn from the body of the patient.
[0069] The device 100 of the present disclosure offers several advantages over the conventional devices. Unlike conventional devices which may require an open surgery to create an anastomosis between two blood vessels, the device 100 of the present disclosure can create an anastomosis via a minimally invasive procedure by using the delivery system 200 of the present disclosure. The procedure being minimally invasive reduces patient trauma and shortens the recovery time. Further, due to shape and structure of the device 100 the anastomosis remains stable and there are reduced chances of migration from the device from the site of anastomosis.
[0070] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM
1. An anastomosis device (100), comprising:
a. a resilient member (110) braided from multiple filaments (170), includes:
i. a canopy (111) disposed towards a distal end (100b) of the device (100); and
ii. a shaft (113) extending from the canopy (111) and disposed towards a proximal end (100a) of the device (100), the shaft (113) includes a channel 117 extending from the proximal end (100a) to the distal end (100b); and
b. a support member (130) disposed coaxially within the shaft (113) of the resilient member (110).
2. The device (100) as claimed in claim 1, wherein each filament (170) of the multiple filaments (170) is jointless traversing a path from the proximal end (100a) and back to the proximal end (100a) after defining the shaft (113) and the canopy (111).
3. The device (100) as claimed in claim 1, wherein the filaments (170) form an outer layer and an inner layer, of the device (100).
4. The device (100) as claimed in claim 3, wherein the outer layer and the inner layer define an annular gap in which the support member (130) is disposed.
5. The device (100) as claimed in claim 1, wherein braiding density of the filaments (170) increases from an outer edge (111c) of the canopy (111) to the channel (117).
6. The device (100) as claimed in claim 1, wherein braiding density of the filaments (170) of the shaft (113) is higher than braiding density of the outer edge (111c) of the canopy (111).
7. The device (100) as claimed in claim 1, wherein the canopy (111) is bent towards the central axis of the device (100).
8. The device (100) as claimed in claim 1, wherein the support member (130) is tubular with a hollow interior.
9. The device (100) as claimed in claim 1, wherein the support member (130) is tapered at its proximal and distal end.
10. The device (100) as claimed in claim 1, wherein the support member (130) includes a plurality of spikes (134) along a central axis of the support member (130).
11. The device (100) as claimed in claim 10, wherein the spikes (134) protrude through the shaft (113), exposing tips of the spikes (134) out of the resilient member (110).
12. The device (100) as claimed in claim 1, wherein the support member (130) includes a plurality of cutouts (136), equally spaced around the support member (130).
13. The device (100) as claimed in claim 1, wherein the support member (130) is metallic.
14. The device (100) as claimed in claim 1, wherein the filaments (170) are made of nitinol.