Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

TITLE OF THE INVENTION
SELF-EXPANDABLE STENT

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
[1] The present disclosure relates to an implant. More particularly, the present disclosure relates to a self-expandable stent.
BACKGROUND OF INVENTION
[2] Aneurysm is a condition where the walls of the vasculatures weaken resulting in abnormal widening or ballooning of the vessel resembling a saccular structure or bulge on a side of a blood vessel. Aneurysm may be caused due to break down of the proteins of the vessel walls and also other factors such as old age, family history, genetic factors and conditions like atherosclerosis which cause hardening of the vessel wall because of deposition of a plague. An aneurysm continues to increase in size along with the progressive weakening of the vessel wall because of the continuous blood supply to the blood vessel.
[3] Methods to treat aneurysms include for example, surgical clipping, inserting micro coils inside the aneurysm, use of embolic materials to fill and pack an aneurysm, using detachable balloons or coils, use of intravascular stents, etc.
[4] In the method wherein a compressed stent is deployed in the target area, the stent may migrate into the blood stream. Due to this migration, the stent may not be able to restrict the blood flow towards the target area. Further, given a stent may be made of a dense metal, it may cause metal related complications inside the body.
[5] In addition, it may not be possible to recapture a conventionally available implant during or after its deployment because of its complex design. Further, once the implant is deployed, it repositioning or retrieval of the implant from the target site is difficult and involves a very complex procedure.
[6] Thus, there arises a need for an implant that overcomes the problems associated with the conventional implants.
SUMMARY OF INVENTION
[7] 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.
[8] The present disclosure relates to an implant. The implant has a proximal end and a distal end on which a first arm and a second arm are situated respectively. The implant has a body provided between the first arm and the second arm. The first arm is provided with a first anchor which defines the distal end of the implant and the second arm is provided a second anchor which defines the proximal end of the implant. An assembly of a delivery apparatus and the implant wherein the delivery apparatus has a sheath and a tube. The tube has a basket towards its distal end. The basket is provided with plurality of struts and a ring. The basket accommodates the second anchor of the implant for re-sheathing the implant.
BRIEF DESCRIPTION OF DRAWINGS
[9] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[10] Fig. 1 depicts an isometric view of an implant 100, according to an embodiment of the present disclosure.
[11] Fig. 2 depicts a front view of the implant 100, according to an embodiment of the present disclosure.
[12] Fig. 3 depicts a side view of the implant 100, according to an embodiment of the present disclosure.
[13] Fig. 4 depicts the placement of the implant 100 inside the blood vessel, according to an embodiment of the present disclosure.
[14] Fig, 5A depicts a delivery apparatus 500, according to an embodiment of the present disclosure.
[15] Fig. 5B depicts the distal end of the delivery apparatus 500 in a closed configuration, according to an embodiment of the present disclosure.
[16] Fig. 5C depicts the distal end of the delivery apparatus 500 in an open configuration, according to an embodiment of the present disclosure.
[17] Fig. 6 depicts the process of deployment of the implant 100 inside the body, according to an embodiment of the present disclosure.
[18] Fig. 7A – 7F depicts the implant 100 in various stages of deployment, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[19] 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.
[20] 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.
[21] 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.
[22] 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.
[23] The present disclosure relates to an implant. In an embodiment, the implant is placed in a blood vessel to treat a neurovascular condition such as an aneurysm for example, a T-junction aneurysm. The implant may be delivered to a target site via a transcatheter technique. The implant includes a body with at least two arms. In an embodiment, the implant is used as a flow adjuster. The implant is used to divert blood flow away from the blood vessel and reduce the pressure therebetween, thus, preventing blood to reach the aneurysm and avoid further budging of the blood vessel.
[24] The implant includes a slender structure. Due to this, minimal metal is inserted/implanted inside a patient body, preventing serious complications arising due to metal allergies. For example, the implant of the present disclosure is designed in such a way that the proportion of metal in the implant is reduced by 60 to 70 % as compared to a conventional metal implant, reducing metal related complications inside the body and improving patient recovery.
[25] Further, the implant is pre-loaded on a catheter. Thus, during a neurovascular procedure, a surgeon has complete control in maneuvering and placing the implant inside a patient body. This reduces risk to a patient during deployment of the implant and also any complication that may arise as a result of the procedure.
[26] In an embodiment, the implant includes an anchor towards at least one of the ends its arms. This enables a surgeon to recapture the deployed implant via the anchor easily in case the implant is incorrectly deployed at the target site. Further, the implant is made from a flexible and/or self-expandable material because of which the implant can be re-sheathed offering easy repositioning of the implant during a medical procedure. Additionally, or optionally, the implant may be made of a radiopaque material which enable noninvasive evaluation of the implant and increase visibility of the implant after deployment. The implant of the present disclosure can be used at multiple vasculature sites including without limitation a neuro vasculature, a peripheral vasculature, an aortic anatomy or anywhere in the body in order to prevent blood flow in the vessel.
[27] Fig. 1 depicts an implant 100 in accordance with an embodiment of the present invention. The implant 100 has a proximal end 100a and a distal end 100b. The implant 100 may have dimensions ranging from 10 mm to 65 mm. In an embodiment, the implant 100 has a lower French size of 1.3Fr and maximum up to 24Fr. The implant 100 is made up of a self-expandable and/or radiopaque material such as without limitation Nitinol, Platinum Tungsten, Platinum Iridium, Tantalum, etc. In an embodiment, the implant 100 is made of Nitinol.
[28] The implant 100 includes a body 130 with at least two arms. For example, the at least two arms include a first arm 110, and a second arm 120. The first arm 110 is situated towards the proximal end 100a and the second arm 120 is situated towards the distal end 100b of the implant 100. The body 130 is provided between the first arm 110 and the second arm 120 to establish a connection therebetween.
[29] The first arm 110 has a first end 110a and a second end 110b. The first arm 110 is made of a solid body having a geometrical shape. For example, the body of the first arm 110 is shape set to form a helical structure. Alternately, the shape of the first arm 110 may include without limitation, a coil shape, zig-zag shape, or any other geometrical shape. The helical structure offers smooth surface without any shape end/edges and further prevents vessel injury.
[30] The first arm 110 may have a pre-defined diameter ranging from 0.050 mm to 0.150 mm. In an embodiment, the first arm 110 has a diameter of 0.070mm. The body of the first arm 110 may include multiple turns ranging between 1 to 5 turns. In an embodiment, the body includes one turn. Once positioned at a target site, the first arm 110 surrounds the periphery of the target blood vessel gently pressing the inner walls of the target blood vessel.
[31] The first arm 110 is provided with a first anchor 110c. In an embodiment, the first anchor 110c is situated towards the first end 110a of the first arm 110. The first anchor 110c defines the distal end of the of the implant 100. The first anchor 110c may be a solid body or a coiled structure. The first anchor 110c may have a shape such as without limitation oval, round, droplet or any other geometrical shape. In an embodiment, the first anchor 110c resembles a droplet. In an embodiment, the first anchor 110c is provided with a smooth surface to prevent trauma to the inner surface of the blood vessel. The first anchor 110c prevents the implant 100 from migrating into the blood stream during heavy blood flow.
[32] The second end 110b of the first arm 110 is connected to the first edge 130a of the body 130. In the depicted embodiment, the second end 110b is connected at the center of the first edge 130a of the body 130 to achieve balance and prevent migration. However, depending upon the shape of the first arm 110, the second end 110b can be connected at a point of the first edge 130a that offers maximum stability to the implant 100 inside a blood vessel.
[33] The second arm 120 has a first end 120a and a second end 120b. The second end 120b is coupled to the second edge 130b of the body 130 (as shown in Fig. 2). The second end 120b is provided with a second anchor 120c situated towards the first end 120a of the second end second arm 120. The second anchor 120c defines the proximal end of the implant 100. The second arm 120 has a structure and function similar to that of the first arm 110, hence, the structure and function of the first arm are applicable the second arm and not repeated for the sake of brevity.
[34] The body 130 includes a first edge 130a, a second edge 130b, a first face 130a and a second face 130b. The body 130 may resemble a thin plate having a shape such as without limitation square, rectangular, or any geometrical shape. In an embodiment, the body 130 has a rectangular shape with curved corners. At least one face of the body 130 may be meshed. For example, the first face 130c and second face 130d of the body 130 may be provided with a meshed surface. The meshed surface may include a diamond mesh, a square mesh, a zig-zag mesh, etc. In an embodiment, the meshed surface is a diamond mesh. The meshed surface of the body 130 prevents blood from entering into the aneurysm.
[35] In an embodiment, the first face 130a and the second face 130b define a curve (depicted in Fig. 3) complementing the inner wall of the blood vessel where the implant is placed, allowing better positioning of the implant 100. The curve may vary from 02mm to 35mm.
[36] In an embodiment, the implant may be coated with phospholipid, phosphorylcholine, etc. to impart anti-bacterial properties.
[37] The following components of the implant 100 as mentioned above may be manufactured as individual components which are subsequently welded or coupled to form the implant 100. Alternately, the components may be laser cut from a single sheet and processed through a defined process including the steps laser cutting, deburring, heat setting, welding, electro-polishing, etc. to yield an integrated structure. In an embodiment, the implant 100 is manufactured as a single integrated structure.
[38] Fig. 4 depicts the implant 100 in a deployed condition inside a blood vessel. ‘A’ indicates a target blood vessel and ‘B’ indicates the aneurysm in the blood vessel. Once implanted, the body 130 of the implant 100 covers the neck of the aneurysm. The arms of the implant are positioned inside the target blood vessel ‘A’ post deployment of the implant. The implant 100 may be delivered to the target blood vessel via a minimal invasive procedure such as a transcatheter technique. The implant 100 of the present disclosure is deployed inside the blood vessel in any delivery apparatus during the medical procedure.
[39] Fig. 5A depicts an exemplary delivery apparatus 500, according to an embodiment. The delivery apparatus 500 is specifically designed for the deployment of the implant 100 of the present disclosure. The delivery apparatus 500 may be a catheter, a braided stent delivery system, a laser-cut stent delivery system, valve delivery system, etc. The delivery apparatus 500 includes a sheath 510, a tube 520 and a hub 530. The tube 520 is encapsulated inside the sheath 510 of the delivery apparatus 500. The tube 520 travels throughout the length of the sheath 510. The tube 520 is provided with a re-sheathing mechanism towards its distal end. The tube 520 has a basket 540 mounted on the distal end of the tube 520. The basket 540 functions to accommodate the second anchor 120c of the implant 100. In an embodiment, the basket 540 is laser cut and helix shaped. The basket 540 includes a plurality of struts 540a and a ring 540b towards its distal end. The ring 540b is resilient in nature, hence, can be expanded on application of a force. Due to resiliency of the ring, the basket can attain one of a closed or an open configuration.
[40] Fig. 5B and 5C depicts the basket 540 in a closed configuration and an open configuration respectively. When the basket 540 is subjected to a force, the plurality of struts 540a and the ring 540b of the basket remain collapsed. For example, when the basket 540 is inside the sheath 510, a force is exerted by the sheath 510 on the ring 540b and the plurality of struts 540a due to which they collapse. In an exemplary embodiment, the basket 540 may depict an oval shape due to plurality of struts 540a and ring 540b being collapsed, as depicted. The basket 540 is thus in a closed configuration and may or may not include the anchor 120c. In case the basket 540 includes the anchor 120c, the anchor 120c is positioned towards the proximal end of the basket 540.
[41] However, when a force is released on the basket 540, for example, due to removal of the sheath, the ring 540b and the plurality of struts 540a expand. The plurality of struts 540a of the basket 540 form a bulge. The basket 540 is thus in open configuration. It is possible that the second anchor 120c is held in the basket 540 in open configuration just before the deployment of the second anchor 120 or while retrieval of the second anchor 120 from the target site.
[42] The basket 540 may be connected to the tube 520 via a mechanism such as without limitation a suture, welding, etc. In an embodiment, the basket 540 is connected to the tube 520 via bonding.
[43] Fig. 6 depicts the process of deployment of the implant 100 inside the body.
[44] At step 600, the implant 100 is first encapsulated completely inside a sheath 510 of a delivery apparatus 500. The implant 100 being made of a self-expandable material, is encapsulated inside a sheath 510 for delivery in the target blood vessel ‘A’. Once inside the sheath 510, the implant 100 is compressed to a minimum diameter for delivery as depicted in Fig. 7A.
[45] At step 602, the delivery apparatus 500 is maneuvered inside the blood vessel ‘A’ till it reaches the implantation site. The delivery apparatus 500 may be maneuvered under fluoroscopic guidance or delivered by use of a guidewire. Care should be taken that the delivery apparatus is so placed inside the blood vessel that the body of the implant 100 should coincide with the neck of the aneurysm.
[46] At step 604, once positioned at the implantation site correctly, the sheath 510 is withdrawn slowly. First, the first anchor of the first arm 110 of the implant 100 is exposed inside the blood vessel ‘A’ followed by exposure of the first arm 110 completely as depicted in Fig. 7B. As the sheath is withdrawn further, the implant is further exposed in the blood vessel. The unsheathed portion of the implant expands as the sheath restrain is removed. Fig. 7C depicts the body of the implant in semi-expanded state as the portion of the body that is unrestrained by the sheath expands while the portion enclosed by the sheath, is compressed.
[47] At step 606, the sheath is continuously withdrawn as in Figs. 7D, 7E and 7F till the second anchor attached to the basket is exposed. Once the second anchor is decoupled from the basket, the implant is entirely implanted at step 608. The struts and the ring of the basket also expand to attain the expanded or relaxed state where no force is applied on them.
[48] In case the implant is to be re-sheathed, the basket is positioned adjacent to the second anchor of the second arm. The surgeon may maneuver the basket such that the basket may hook with the second anchor. In an exemplary embodiment, the surgeon may maneuver till the second anchor is at least partially captured by the basket, say portion from a proximal end of the second anchor till the position having maximum diameter. Once the second anchor is seated in the basket, the tube can be pulled inside the sheath till the entire implant is withdrawn for replacement.
[49] Though the implant 100 of the present invention is described in context to treat aneurysms, the teachings of the present invention may also be used to treat other vascular related conditions such as neuro aneurysms, peripheral aneurysms, embolization of vessels etc.
[50] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM:
1. An implant (100) comprising;
a) a proximal end (100a) and a distal end (100b);
b) a first arm (110) situated towards the proximal end (100a);
c) a second arm (120), situated towards the distal end (100b)
d) a body (130) provided between the first arm (110) and the second arm (120);
e) a first anchor (110c) provided with the first arm (110), the first anchor (110c) defines the distal end; and
f) a second anchor (120c) provided with the second arm (120), the second anchor (120c) defines the proximal end.
2. The implant (100) as claimed in claim 1, wherein the first arm (110) and the second arm (120) are made of a solid body.
3. The implant (100) as claimed in claim 1, wherein at least one of the first arm (110) and the second arm include a helical structure.
4. The implant (100) as claimed in claim 3, wherein the helical structure includes 1 to 5 turns.
5. The implant (100) as claimed in claim 1, wherein the body (130) includes at least one meshed surface to prevent migration of the implant.
6. The implant (100) as claimed in claim 5, wherein the meshed surface includes a diamond mesh.
7. The implant (100) as claimed in claim 1, wherein the body (130) includes a plate of a geometrical shape.
8. The implant (100) as claimed in claim 1, wherein at least one of the first anchor and the second anchor include one of a solid body or a coiled structure.
9. The implant (100) as claimed in claim 1, wherein the implant (100) is coated with at least one of phospholipid and phosphorylcholine.
10. The implant (100) as claimed in claim 1, wherein the implant (100) is made of a self-expandable material.
11. An assembly of a delivery apparatus (500) and an implant (100), the delivery apparatus (500) comprises;
i. an implant as claimed in claim 1; and
ii. a delivery apparatus including:
a) a sheath (210); and
b) a tube (520) having a basket provided towards its distal end, the basket (540) includes a plurality of struts (540a) and a ring (540b), the basket (540) is configured to accommodate the second anchor (120c) of the implant (100) for re-sheathing the implant.