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:
IMPLANT FOR IMPROVED BLOOD FLOW

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
[1] The present disclosure relates to a medical device. More particularly, the present disclosure relates to an implant for improving blood flow across a blood vessel
BACKGROUND OF INVENTION
[2] Refractory angina is a condition with symptoms like chronic chest pain due to reduced blood supply to the heart muscle. Conventional course of treatment for such condition includes medications, angioplasty and/or coronary artery bypass grafting (CABG). With the former two course of treatments, many patients stop responding positively after repeated angina episodes. And the latter course of treatment is one of the high-risk invasive surgeries and has very long periods of recovery time. Further, the CABG procedure may not be suitable to most patients, for instance, older patients.
[3] Conventionally, as alternatives to the aforesaid treatments, a balloon-expandable implant having a substantially tapered structure is temporarily implanted at the superior vena cava (SVC) and/or the inferior vena cava (IVC) for a short period of time (for example, for 8 to 72 hours). However, the deployment procedure of such a balloon-expandable implant and its subsequent retrieval takes a lot of surgical time. Further, these implants are prone to dislodgement and migration because of their substantially tapered structure causing medical complications.
[4] Thus, there arises a need for an implant that overcomes the problems associated with conventional implants.
SUMMARY OF INVENTION
[5] 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.
[6] In an exemplary embodiment, the present disclosure relates to an implant including a proximal portion disposed at a proximal end, a distal portion disposed at a distal end, and a plurality of studs. Each of the proximal portion and the distal portion includes a peripheral portion having a pre-defined diameter and a middle portion disposed adjacent to the peripheral portion and coupled thereto via a plurality of second links. The peripheral portion includes a first row of first angled struts disposed either at the proximal end and the distal end, and a second row of second angled struts coupled to the first row of first angled struts via a plurality of first links. The diameter of the middle portion reduces from a maximum diameter at the peripheral portion to a minimum diameter. The middle portions include at least one row of connectors. The connectors have two elongated stems ‘g’ and two flared arms ‘h’. The flared arms ‘h’ of each of the connector are coupled to alternate pairs of second angle struts of the second row via the second links. The plurality of studs couples the stems ‘g’ of the connector of the proximal portion to respective stems ‘g’ of an adjacently disposed connector of the distal portion, thereby coupling the middle portions of the proximal portion and the distal portion. The pre-defined diameter of the peripheral portions of the proximal portion and the distal portion is the same.
[7] In another exemplary embodiment, the present disclosure relates to an implant including a proximal portion disposed at a proximal end, a distal portion disposed at a distal end, and a plurality of studs. Each of the proximal portion and the distal portion includes a peripheral portion having a pre-defined diameter, a middle portion disposed adjacent to the peripheral portion and coupled thereto via a plurality of second links. The peripheral portion includes at least two rows of circumferentially arranged angled struts coupled to each other via a plurality of first links. The diameter of the middle portion reduces from a maximum diameter at the peripheral portion to a minimum diameter. The middle portions include at least one row of connectors coupled to one row circumferentially arranged angled struts from the at least two circumferentially arranged angled struts of the peripheral portion via the second links. The connectors having two elongated stems ‘g’ and two flared arms ‘h’. At least one first linking strut couples the adjacently disposed flared arms ‘h’ of two adjacently disposed connectors. The plurality of studs couples the stems ‘g’ of the connector of the proximal portion to respective stems ‘g’ of an adjacently disposed connector of the distal portion, thereby coupling the middle portions of the proximal portion and the distal portion. The pre-defined diameter of the peripheral portions of the proximal portion and the distal portion is the same.
BRIEF DESCRIPTION OF DRAWINGS
[8] 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.
[9] Fig. 1 depicts an implant 100 deployed across the coronary sinus, according to an embodiment of the present disclosure.
[10] Fig. 2 depicts a radially expanded state of the implant 100, according to an embodiment of the present disclosure.
[11] Fig. 3 depicts a radially collapsed state of the implant 100, according to an embodiment of the present disclosure.
[12] Fig. 4 depicts a two-dimensional spread-out view of the implant 100, according to an embodiment of the present disclosure.
[13] Fig. 4a depicts a peripheral portion 110 of the implant 100, according to an embodiment of the present disclosure.
[14] Fig. 4b depicts a middle portion 130 of the implant 100, according to an embodiment of the present disclosure.
[15] Fig. 5 depicts a two-dimensional spread-out view of an implant 200, according to an embodiment of the present disclosure.
[16] Fig. 6 depicts a two-dimensional spread-out view of an implant 300, according to an embodiment of the present disclosure.
[17] Fig. 7 depicts a method 700 for manufacturing the implant 100/200/300, according to an embodiment of the present disclosure.
[18] Fig. 8 depicts a method 800 for deployment of the implant 100/200/300, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE 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] Until and unless explicitly stated otherwise, the description of the implant of the present disclosure is described in its radially expanded state.
[24] The present disclosure relates to an implant. The implant increases/improves blood pressure by reducing blood flow across the implant (and the blood vessel the implant is deployed in).
[25] In an exemplary embodiment, the implant is deployed across a pre-defined portion of a coronary sinus. The coronary sinus is a major vein that drains deoxygenated blood from the heart muscle. The implant narrows at least a portion of the coronary sinus, thereby increasing blood pressure across the vein which leads to improved blood flow in the ischemic areas of the heart where the blood supply is insufficient. After implantation, the implant significantly reduces the frequency and severity of angina episodes, thereby improving the quality of life for the patients suffering from conditions like refractory angina or the like.
[26] Now referring to the figures, Fig. 1 depicts an implant 100 deployed across a vein 10. In an exemplary embodiment, the vein 10 is the coronary sinus. The vein 10 receives deoxygenated blood from the artery 30 through the capillaries 50. The artery 30 may have depositions 31 causing stenosis. Due to stenosis, the muscles (for example, the heart muscles) may not receive sufficient blood supply causing refractory angina.
[27] The implant 100 narrows at least a portion of the vein 10, thereby increasing pressure across the vein 10 which leads to improved blood flow in the artery 30 (for example, the ischemic areas of the heart). After implantation, the implant 100 significantly reduces the frequency and severity of angina episodes, thereby improving the quality of life for the patients suffering from conditions like refractory angina or the like.
[28] Fig. 2 depicts the implant 100 of the present disclosure. The implant 100 has a pre-defined shape including, but not limited to, hour-glass, octagonal-conical hybrid (i.e., starts with an octagonal cross-section and gradually transitions to a circular cross-section), etc. In an exemplary embodiment, as shown in Fig. 2, the implant 100 has an hour-glass shape. The hour-glass shape of the implant 100 easily conforms to vessels having diameter ranging from 9.5 mm to 13 mm and effectively creates a pressure gradient across it.
[29] The implant 100 is made by cutting the structure of the implant 100 from a tube made of one or more self-expandable and biocompatible materials, for example, nitinol (nickel-titanium alloy). The thickness (or wall thickness) of the tube ranges from 100 µm to 250 µm. In an exemplary embodiment, the implant 100 is fabricated from a 250 µm thick (i.e., wall thickness) tube made of nitinol (nickel-titanium alloy) using a laser cutting technique. Due to the self-expandable property of the material, the implant 100 is self-expandable from a radially collapsed state (as shown in Fig. 3) to a radially expandable state (as shown in Fig. 2) for quick and easy deployment of the implant 100. Similarly, the implant 100 may be crimped to the radially collapsed state from the radially expanded state, enabling deployment of the implant 100 using a minimally invasive technique (such as, via a transcatheter based technique). Minimally invasive deployment of the implant 100 reduces the recovery time and minimizes risks associated with invasive surgeries and procedural complications.
[30] As shown in Fig. 2, the implant 100 includes a proximal end 100a, a distal end 100b and a length extending therebetween. The length of the implant 100 ranges from 15 mm to 30 mm. In an exemplary embodiment, the length of the implant 100 is 22 mm. The implant 100 defines two substantially symmetrical portions, namely a proximal portion 101 disposed towards the proximal end 100a and a distal portion 103 disposed towards the distal end 100b. As shown in Fig. 2, the distal portion 103 is a mirror image of the proximal portion 101. For sake of brevity, only the proximal portion 101 of the implant 100 is described in detail which mutatis mutandis is applicable to the distal portion 103 of the implant 100.
[31] The proximal portion 101 includes a peripheral portion 110 disposed at the proximal end 100a and a middle portion 130 disposed away from the proximal end 100a and adjacent to the peripheral portion 110. The peripheral portions 110 of the implant 100 may have a pre-defined structure including, but not limited to, cylindrical, polygonal (for example, pentagonal, hexagonal, heptagonal, octagonal, etc.). In an exemplary embodiment, as shown in Fig. 2, the peripheral portion 110 of the implant 100 has a substantially cylindrical structure. The cylindrical structure of the peripheral portions 110 help the implant 100 to exert uniform radial force to the surrounding vessel, thereby conforming to the anatomy. The cylindrical structure of the peripheral portions 110 prevents the implant 100 from dislodgement and migrations. The cylindrical structure of the peripheral portion 110 imparts excellent radial strength to the implant 100 that provides structural support to the coronary sinus and prevents prolapse of the coronary sinus over time. In an alternate embodiment, not shown, the peripheral portion of the implant is polygonal having 8 sides.
[32] The peripheral portions 110 of the implant 100 may have a length ranging from 3 mm to 12 mm. The peripheral portions 110 of the implant 100 may have a pre-defined diameter ranging from 5 mm to 15 mm. In case the peripheral portion 110 has a polygonal structure, the diameter of the peripheral portion 110 corresponds to the maximum cross-sectional width of the polygonal structure. The diameter of the peripheral portion 110 may either be the same or vary across the length of the peripheral portions 110. The diameter of the peripheral portions 110 of the proximal portion 101 and the distal portion 103 may either be the same or different. In an exemplary embodiment, the length and diameter of the peripheral portion 110 are 9 mm and 12 mm, respectively. As shown in Fig. 2, the diameter of the peripheral portions 110 of both the proximal portion 101 and the distal portion 103 is the same across the length of the peripheral portions 110.
[33] The middle portions 130 of the implant 100 may have a pre-defined structure including, but not limited to, conical, pentagonal-conical hybrid, hexagonal-conical hybrid, heptagonal-conical hybrid, octagonal-conical hybrid, etc. In an exemplary embodiment, as shown in Fig. 2, the middle portion(s) 130 of the implant 100 in its radially expanded state has a substantially conical structure. The conical structure of the middle portions 130 helps the implant 100 to narrow the blood flow path across the blood vessel, thereby increasing pressure. If the middle portion is polygonal (not shown), the side of the polygonal is the same as the side of the polygonal structure of the peripheral portion.
[34] The middle portions 130 of the implant 100 in its radially expanded state may have a maximum diameter and a minimum diameter. The diameter of the middle portions 130 either gradually or abruptly tapers (reduces) from the maximum diameter at the peripheral portions 110 to the minimum diameter. The maximum diameter of the middle portions 130 is the same as the diameter of the peripheral portion 110. The middle portions 130 of the implant 100 may have a minimum diameter ranging from 2 mm to 6 mm. The middle portions 130 of the implant 100 may have a length ranging from 5 mm to 15 mm. In an exemplary embodiment, the length and minimum diameter of the middle portion 130 is 12 mm and 3 mm, respectively. As shown in Fig. 2, the diameter of the middle portions 130 gradually tapers from the maximum diameter to the minimum diameter across the length of the middle portions 130, thereby defining a taper angle between the middle portion 130 and the peripheral portion 110. The taper angle ranges from 100° to 160°. In an exemplary embodiment, the taper angle is 125°.
[35] As shown in Fig. 4, the peripheral portion 110 includes at least two rows of circumferentially arranged angled struts. In an embodiment, the peripheral portion 110 includes two rows of circumferentially arranged angled struts, namely a first row 111 and a second row 113. The first row 111 is disposed at the proximal end 100a and the second row 113 is disposed between the proximal end 100a and middle portion 130. Although the peripheral portions 110 of the implant 100 is described with examples of only two rows of angled struts, the peripheral portions 110 may include more than two rows of angled struts depending upon requirements.
[36] The first row 111 includes a plurality of first angled struts 111a in a zig-zag pattern. The number of first angled struts 111a may depend upon the diameter of the peripheral portions 110. The first angled struts 111a may each be straight, wavy. In an exemplary embodiment, the first angled struts 111a are straight. Each pair of adjacent first angled struts 111a define a pre-defined shape. In an exemplary embodiment, as shown in Fig. 4a, the pair of adjacent first angled struts 111a define a V-shape with elongated stem (bottom) ‘a’ and flared tips ‘b’. The stems ‘a’ of the first angled struts 111a are disposed at the proximal end 100a. The adjacently disposed first angled struts 111a are coupled to each other at the adjacently disposed tips ‘b’ and the stems ‘a’ of the respective first angled struts 111a in a zig-zag pattern. The pair of adjacent first angled struts 111a has a pre-defined angle ‘c’ (as shown in Fig. 4a) that varies depending upon the length of the first angled struts 111a. The angle ‘c’ may either be the same or different for each of the pairs of adjacent first angled struts 111a. In an exemplary embodiment, the angle ‘c’ of all pairs of adjacent first angled struts 111a is the same.
[37] The length of the first angled struts 111a may range from 2 mm to 6 mm. The length of the first angled struts 111a may either be the same or different. In an exemplary embodiment, as shown in Fig. 4a, the length of all first angled struts 111a is the same, and is equal to 5 mm. The width of the first angled struts 111a may range from 0.18 mm to 0.28 mm. The width of the first angled struts 111a may either be the same or different. In an exemplary embodiment, the width of all first angled struts 111a is 0.25 mm.
[38] Additionally or optionally, one or more eyelets 115 are disposed at the proximal end 100a, the distal end 100b or both and coupled to respective peripheral portions 110. The peripheral portion(s) 110 of either the proximal portion 101, the distal portion 103 or both the proximal portion 101 and the distal portion 103 are provided with the eyelets 115. As shown in Fig. 4 and 4a, the stem ‘a’ of at least one pair of adjacent first angled struts 111a is coupled with the eyelet 115. In an exemplary embodiment, as shown in Fig. 4, the eyelets 115 are coupled to the stems ‘a’ of alternate pairs of adjacent first angled struts 111a. The eyelet 115 has a pre-defined shape including, but not limited to, circular etc. In an exemplary embodiment, the eyelets 115 are circular. The eyelet 115 has a pre-defined diameter ranging from 0.5 mm to 0.6 mm. In an exemplary embodiment, the diameter of the eyelet 115 is 0.53 mm.
[39] The eyelets 115 are configured to receive at least one radiopaque marker (not shown). The radiopaque marker is coupled to the eyelet 115 via at least one of welding, bonding, etc. In an exemplary embodiment, the radiopaque marker is coupled to the eyelet 115 by welding. The radiopaque marker may be made of one or more materials including, but not limited to, platinum, tantalum, etc. The radiopaque marker helps the medical practitioner to view the implant 100 in vivo with the help of a fluoroscopy imaging technique or the like.
[40] The second row 113 includes a plurality of second angled struts 113a arranged in a zig-zag pattern. The number of second angled struts 113a may depend upon the diameter of the peripheral portions 110. The second angled struts 113a may each be straight, wavy, etc. In an exemplary embodiment, the second angled struts 113a are straight. Each pair of adjacent second angled struts 113a define a pre-defined shape including but not limited to, V-shaped, U-shaped, etc. In an exemplary embodiment, as shown in Fig. 4a, each pair of adjacent second angled struts 113a defines a V-shape with a short stem (bottom) ‘d’ and flared tips ‘e’. The stems ‘d’ of the second angled struts 113a are disposed adjacent the middle portion 130. The adjacently disposed second angled struts 113a are coupled to each other at the adjacently disposed tips ‘e’ and stems ‘d’ of the respective second angled struts 113a in a zig-zag pattern. The pair of adjacent second angled strut 113a has a pre-defined angle ‘f’ (as shown in Fig. 4a) that varies depending upon the length of the second angled struts 113a. The angle ‘f’ may either be the same or different for each of the pairs of adjacent second angled struts 113a. In an exemplary embodiment, the angle ‘f’ of all pairs of adjacent second angled struts 113a is the same.
[41] The length of the second angled struts 113a may range from 1.5 mm to 4 mm. The length of the second angled struts 113a may either be same or different for each of the second angled struts 113a. In an exemplary embodiment, as shown in Fig. 4, the length of all second angled struts 113a is the same, and is equal to 3 mm. The length of the second angled struts 113a may either be same as or smaller or larger than the length of the first angled struts 111a. As shown in Fig. 4, the length of the first angled struts 111a is larger than the length of the second angled struts 113a. The relatively longer first angled struts 111a compared to the second angled struts 113a is easier to manufacture and provides better radial expansion when the implant 100 is radially expanded from its radially collapsed stated to its radially expanded state. The width of the second angled strut 113a may range from 0.18 mm to 0.28 mm. In an exemplary embodiment, the width of the second angled strut 113a is 0.25 mm.
[42] The at least two rows of circumferentially arranged angled struts of the peripheral portion 110 are coupled to each other via a plurality of first links 117. The first angled struts 111a and the second angled struts 113a are arranged such that the tips ‘e’ of each pair of adjacent second angled struts 113a are disposed adjacent to the tips ‘b’ of a respective pair of adjacent first angled struts 111a. As shown in Figs. 4 and 4a, the second angled struts 113a of the second row 113 are coupled to the first angled struts 111a of the first row 111 via the plurality of first links 117, thereby defining a row 119 of closed cells 119a. The first links 117 may have a pre-defined shape including, but not limited to, straight, Z-shape, etc. In an exemplary embodiment, as shown in Fig. 4, the first links 117 are straight. The first links 117 may have a length ranging from 0.3 mm to 0.5 mm. The first links 117 may have a width ranging from 0.2 mm to 0.4 mm. In an exemplary embodiment, the length and width of the first links 117 are 0.45 mm and 0.33 mm respectively.
[43] In an exemplary embodiment, as shown in Figs. 4 and 4a, each pair of adjacently disposed tips ‘e’ of the second angled struts 113a and tips ‘b’ of the first angled struts 111a are coupled to each other via one first link 117. In other words, one pair of adjacent first angled struts 111a of the first row 111 and one pair of adjacent second angled struts 113a of the second row 113 are coupled to each other via two first links 117, thereby defining one closed cell 119a.
[44] The closed cell 119a may have a pre-defined shape including, but not limited to, diamond, rhombus etc. In an exemplary embodiment, as shown in Figs. 4 and 4a, the closed cell 119a is diamond shaped. The length of the closed cell 119a ranges from 4 mm to 11 mm. In an exemplary embodiment, the length of the closed cell 119a is 9 mm.
[45] As shown in Fig. 4, the middle portion 130 includes at least one row of circumferentially arranged connectors. In an embodiment, the middle portion 130 includes one row of circumferentially arranged connectors, namely, a third row 131. The third row 131 includes a plurality of connectors 131a and optionally, a plurality of nested connectors 131b.
[46] The number of connectors 131a may depend upon the diameter of the middle portions 130. The connectors 131a has a pre-defined shape including but not limited to, Y-shaped, V-shaped, etc. In an exemplary embodiment, as shown in Figs. 4 and 4b, the connectors 131a are Y-shaped with two elongated stems (bottom) ‘g’ and two flared arms ‘h’. The arms ‘h’ of the connector 131a are disposed adjacent the stems ‘d’ of the second angled struts 113a. The two flared arms ‘h’ of the connector 131a have a pre-defined angle ‘i’ (as shown in Fig. 4b) that varies depending upon the length of the connector 131a. The angle ‘i’ of the connector 131a may either be same or different for each of the connectors 131a. In an exemplary embodiment, the angle ‘i’ of all connectors 131a is the same. The connectors 131a improves flow of blood by increasing the blood pressure across the implant 100.
[47] The length of the connector 131a may range from 3 mm to 6 mm. The length of the connector 131a may either be same or different for each of the connectors 131a. The length of the connectors 131a may either be same or different than the length of the first angled struts 111a and the second angled struts 113a. In an exemplary embodiment, as shown in Figs. 4 and 4b, the length of all connectors 131a is the same, and is equal to 5 mm. As shown in Fig. 4, the length of the connectors 131a is larger than the length of the second angled struts 113a. The width of the connector 131a may range from 0.12 mm to 0.2 mm. The width of the connector 131a may either be same or different for each of the connectors 131a. In an exemplary embodiment, the width of all connectors 131a is the same, and is equal to 0.16 mm.
[48] The at least one row of connectors 131a of the middle portion 130 is coupled to one row circumferentially arranged angled struts from the at least two circumferentially arranged angled struts of the peripheral portion 110 via a plurality of second links 133. As shown in Fig. 4, the flared arms ‘h’ of each of the connectors 131a of the third row 131 of the middle portion 130 are coupled to the respective stems ‘g’ of alternate pairs of second angled struts 113a of the second row 113 of the peripheral portion 110 via the plurality of second links 133 thereby defining a row 135 of closed cells 135a. Since, in the depicted embodiment, the alternate pairs of second angled struts 113a of the second row 113 are coupled to the connectors 131a, the closed cells 135a are formed alternatingly/discontinuously. The second links 133 may have a pre-defined shape and be parallel with either the peripheral portion 110 or the middle portion 130. In an exemplary embodiment, the second links 133 are straight shaped and parallel with the peripheral portion 110. In another exemplary embodiment, the second links 133 are straight shaped and parallel with the middle portion 130. The second links 133 may have a length ranging from 0.5 mm to 2 mm. The second links 133 may have a width ranging from 0.12 mm to 0.2 mm. In an exemplary embodiment, the length and width of the second links 133 are 1.1 mm and 0.16 mm respectively.
[49] In an embodiment, each alternate pair of adjacently disposed stems ‘d’ of the second angled struts 113a in the second row 113 are connected using one connector 131a. For example, as shown in Figs. 4, 4a and 4b, the alternate pairs of adjacent stems ‘d’ of the second angled struts 113a are coupled to the flared arms ‘h’ of the respective connectors 131a via two second links 133. In other words, one closed cell 135a is formed by one pair of adjacent second angled struts 113a of the second row 113 having adjacent stems ‘d’ respectively coupled to the two flared arms ‘h’ of one connector 131a of the third row 131 via one second links 133 each.
[50] The closed cell 135a may have a pre-defined shape including, but not limited to, diamond, rhombus, etc. In an exemplary embodiment, as shown in Fig. 4, the closed cell 135a is diamond shaped. The length of the closed cell 135a ranges from 3 mm to 8 mm. In an exemplary embodiment, the length of the closed cell 135a is 4.5 mm.
[51] Additionally or optionally, as shown in Fig. 4, at least one connector 131a is provided with the at least one nested connector 131b. In an exemplary embodiment, as shown in Figs. 4 and 4b, all connectors 131a are provided with one nested connector 131b each. The nested connectors 131b have a pre-defined shape including, but not limited to, Y-shaped, V-shaped, etc. In an exemplary embodiment, as shown in Fig. 4b, each of the nested connector 131b are Y-shaped with two short stems (bottom) ‘j’ and two flared tips ‘k’. The stems ‘j’ of each nested connector 131b are disposed towards the stems ‘g’ of the corresponding connector 131a. The two tips ‘k’ of the nested connector 131ba are coupled to the corresponding flared arms ‘h’ of the connector 131a. The tips ‘k’ of the nested connectors 131b have a pre-defined angle ‘l’ (as shown in Fig. 4b) that varies depending upon the length of the nested connector 131b. The angle ‘l’ of the nested connectors 131b may either be same or different for each of the nested connectors 131b. In an exemplary embodiment, the angle ‘l’ of all nested connectors 131b is the same. The nested connectors 131b improves flow of blood by increasing the blood pressure across the implant 100. The nested connector 131b ensures proper radial expansion of the row 135 of the closed cells 135a when the implant 100 is radially expanded from its radially collapsed stated to its radially expanded state.
[52] The length of the nested connectors 131b may range from 1.4 mm to 4 mm. The length of the nested connectors 131b may either be same or different for each of the nested connectors 131b. In an exemplary embodiment, as shown in Fig. 4, the length of all the nested connectors 131b is the same, and is equal to 3 mm. The length of the nested connectors 131b may either be same or different than the length of the connectors 131a. As shown in Fig. 4, the length of the nested connectors 131b is smaller than the length of the connectors 131a. The width of the nested connector 131b may range from 0.08 mm to 0.12 mm. In an exemplary embodiment, the width of the nested connector 131b is 0.1 mm. The width of the nested connectors 131b may either be same or different than the width of the connectors 131a. As shown in Fig. 4, the width of the nested connectors 131b is less than the width of the connectors 131a.
[53] In an exemplary embodiment, as shown in Figs. 4 and 4b, the stems ‘j’ of the nested connector 131b of the implant 100 are free (or free-floating). The free-floating stems ‘j’ of the nested connectors 131b ensures proper radial expansion of the row 135 of closed cells 135a when the implant 100 is radially expanded from its radially collapsed stated to its radially expanded state.
[54] Fig. 5 depicts an implant 200 according to another embodiment of the present disclosure. The implant 200 is structurally the same as implant 100 depicted in Fig. 4, except that the stem ‘j’ of each nested connectors 231b is coupled to the stems ‘g’ of the respective connectors 231a via a linking strut 231c. The linking strut 231c may have a pre-defined shape. In an exemplary embodiment, as shown in Fig. 5, the linking strut 231c is straight. The length of the linking strut 231c ranges from 1.2 mm to 3 mm. The width of the linking strut 231c ranges from 0.06 mm to 0.1 mm. In an exemplary embodiment, the length and width of the linking strut 231c are 2.3 mm and 0.09 mm respectively. The linking strut 231c helps to support the nested connectors 231b and provides more area cover for reducing the blood flow across the implant 100.
[55] The middle portion 130 of the proximal portion 101 and the middle portion 130 of the distal portion 103 are coupled to each other via a plurality of studs 137. In an exemplary embodiment, as shown in Fig. 4, the stems ‘g’ of each connector 131a of the proximal portion 101 is coupled to respective stems ‘g’ of an adjacently disposed connector 131a of the distal portion 103 via one stud 137. The stud 137 may have a pre-defined shape. In an exemplary embodiment, as shown in Fig. 4, the studs 137 are straight. The stud 137 may have a length ranging from 0.4 mm to 0.5 mm. The stud 137 may have a width ranging from 0.1 mm to 0.2 mm. In an exemplary embodiment, the length and width of the stud 137 is 0.46 mm and 0.18 mm respectively. The studs 137 may define an angle with respect to the middle portion 130 that varies depending upon the dimensions of the middle portion 130. The studs 137 provides excellent flexibility to the middle portions 130 of the implant 100.
[56] As shown in Fig. 4b, at least one first linking strut 139a may be disposed between at least two adjacently disposed connectors 131a in a pre-defined arrangement. The first linking struts 139a may be arranged in pre-defined arrangement including, but not limited to, X-like arrangement etc. In an exemplary embodiment, as shown in Figs. 4 and 4b, the adjacently disposed flared arms ‘h’ of adjacently disposed connectors 131a are coupled to each other via two first linking struts 139a in an X-like arrangement. The first linking struts 139a may define a pre-defined length ranging from 0.22 mm to 0.35 mm. The first linking struts 139a may define a pre-defined width ranging from 0.05 mm to 1.5 mm. The length and width of each of the first linking struts 139a may either be same or vary with respect to each other. In an exemplary embodiment, the length and width of the all first linking struts 139a is 0.31 mm and 0.08 mm, respectively. In an exemplary embodiment, the width of the first linking strut 139a is relatively less than the width of the connector 131a. The relatively less width of the first linking struts 139a (compared to the width of the connectors 131a) enhances blood flow while minimizing the risk of thrombosis.
[57] The first linking struts 139a may be coupled to each other to define a pre-defined intersection angle ‘m’ that varies depending upon the length of the first linking struts 139a. The first linking struts 139a may define a pre-defined strut angle ‘n’ with the flared arms ‘h’ of the connectors 131a that varies depending upon the length of the first linking struts 139a. The first linking struts 139a at least partially obstructs the flow of blood between the peripheral portions 110 thereby increasing the blood pressure and reducing the blood flow across the implant 100.
[58] Fig. 6 depicts an implant 300 according to another embodiment of the present disclosure. The implant 300 is structurally the same as implant 100 depicted in Fig. 4, except that at least one first linking strut 339a of the proximal portion 301 is coupled to at least one first linking strut 339a of the distal portion 303, which is adjacently disposed to the at least one first linking strut 339a of the proximal portion 301, via one or more second linking struts 339b. The length of the second linking struts 339b may either be same or different. The second linking struts 339b may define a pre-defined width ranging from 0.06 mm to 0.1 mm. In an exemplary embodiment, the length and width of all second linking struts 339b is 0.8 mm and 0.08 mm respectively. The second linking struts 339b may be arranged in pre-defined arrangement including, but not limited to, X-like arrangement. In an exemplary embodiment, as shown in Fig. 6, the first linking strut 339a of the proximal portion 301 and the first linking strut 339a of the distal portion 303, disposed adjacent to the first linking strut 339a of the proximal portion 301, are coupled to each other via two second linking struts 339b making a X-like arrangement. The second linking struts 339b at least partially obstructs the flow of blood between the peripheral portions 110 thereby increasing the blood pressure and reducing the blood flow across the implant 100.
[59] Fig. 7 depicts an exemplary method 700 of manufacturing the implant 100 of the present disclosure. The method begins at step 701, by cutting the structure of the implant 100 on a tube made of one or more self-expandable and biocompatible materials to obtain the implant 100. The thickness (or wall thickness) of the tube ranges from 100 µm to 250 µm. In an exemplary embodiment, the structure of the implant 100 is laser cut on a tube made of nitinol (nickel-titanium alloy). The thickness of the tube is 250 µm. The laser cutting of the tube ensures precise creation of the implant 100.
[60] At an optional step 703, the implant 100 obtained from step 701 is subjected to a grinding and honing technique. Subjecting the implant 100 to the grinding and honing technique removes any burrs that may arise from cutting the tube at step 701. Removing the burrs from the implant 100 provides a smooth surface to the implant 100.
[61] At step 705, the implant 100 obtained from step 701 or 703 is subjected to a shape-setting process. The shape of the implant 100 (as shown in Fig. 2) is held and subjected to a pre-defined temperature for a pre-defined time period to shape set the implant 100. The shape of the implant 100 may be held using a mandrel or the like. In an exemplary embodiment, the implant 100 is held using an hour-glass shaped mandrel. The pre-defined temperature ranges from 350°C to 650°C. The pre-defined time period ranges from 4 minutes to 8 minutes. In an exemplary embodiment, the implant 100 is held at 500°C for 6 minutes.
[62] At step 707, the implant 100 obtained from step 705 is cooled. In an exemplary embodiment, the implant 100 is cooled to room temperature.
[63] At step 709, the implant 100 obtained from step 707 is subjected to a sand blasting process. Sand blasting the implant 100 helps to remove any oxide layer and micro cracks from the surface of the implant 100 and provides a smooth surface.
[64] In an optional step 711, the implant 100 is subjected to an electro-polishing process. Electro-polishing the implant 100 smoothens the edges, inner surface, outer surface of the implant 100.
[65] At step 713, the radiopaque marker(s) are coupled to implant 100 obtained from step 711. In an exemplary embodiment, the radiopaque markers are couped to the eyelets 115 (as shown in Fig. 4).
[66] At an optional step 715, the implant 100 obtained from step 713 is subjected to a cleaning process. In an exemplary embodiment, the implant 100 is cleaned using isopropyl alcohol to remove any loose debris and/or contaminants present on the surface of the implant 100.
[67] Although the method 700 is described with the example of the implant 100, the method 700 is equally applicable to the implant 200 and the implant 300.
[68] Fig. 8 depicts an exemplary method 800 for deploying the implant 100 within a vasculature, for example, the coronary sinus. The implant 100 may be deployed with the help of a delivery system (not shown) capable to deploy self-expandable stents or the like. As an example, the delivery system includes an outer sheath, an inner sheath and a handle to control the relative movement of the outer sheath and the inner sheath. The inner sheath is movably disposed within the outer sheath of the delivery system. The outer sheath prevents the implant 100 to pre-maturely self-expand while the delivery system is advanced within the vasculature.
[69] Before the method 800 commences, the implant 100 is radially crimped from its radially expanded state to its radially collapsed state with the help of, for example, a crimper (not shown). Thereafter, the implant 100 is loaded into the delivery system by mounting the implant 100 between the inner sheath and the outer sheath of the delivery system. Alternatively, the implant 100 may be available pre-loaded into the delivery system.
[70] The method commences at step 801 by creating a puncture at a pre-defined position and inserting an introducer sheath (not shown) therethrough. In an exemplary embodiment, the jugular vein is punctured and a 9Fr introducer sheath is inserted therethrough.
[71] At step 803, a guidewire (not shown) is advanced through the introducer sheath to the right atrium of the heart.
[72] At step 805, a multipurpose catheter is carefully advanced to the deployment site (i.e., the coronary sinus) over the guidewire avoiding the small branches of the veins.
[73] At step 807, the delivery system is advanced over the guidewire and through the multipurpose catheter. The delivery system is positioned at the deployment site, i.e., the coronary sinus.
[74] At step 809, the implant 100 is exposed from underneath the outer sheath of the delivery system. Exposing the implant 100 allows it to self-expand from its radially collapsed state to its radially expanded state.
[75] In an exemplary embodiment, the implant 100 is deployed by pushing the inner sheath out of the inner sheath of the delivery system. In another exemplary embodiment, the implant 100 is deployed by pulling the outer sheath from over the inner sheath of the delivery system. In yet another exemplary embodiment, the implant 100 is deployed by simultaneously pushing the inner sheath and pulling the outer sheath of the delivery system.
[76] The flexible property of the implant 100 allows it to conform to the anatomy of the coronary sinus (or the like) without any risk of dislodgement or migrations. The self-expanding property of the implant 100 reduces the time to deploy the implant 100 and the risk of procedural complications.
[77] At step 811, delivery system, the multipurpose catheter, the guidewire, and the introducer sheath are withdrawn from the body leaving the implant 100 deployed at the deployment site (i.e., coronary sinus).
[78] The design of the implant 100 enables a minimally invasive procedure via the method 800 to be performed usually under local anesthesia. Thus, the implant 100 reduces recovery time and avoids risks associated with invasive conventional surgeries.
[79] Although the method 800 is described with the example of the implant 100, the method 800 is equally applicable to the implant 200 and the implant 300.
[80] 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, 200, 300) comprising:
a. a proximal end (100a) and a distal end (100b);
b. a proximal portion (101) disposed at the proximal end (100a); and
c. a distal portion (103) disposed at the distal end (100b), each of the proximal portion (101) and the distal portion (103) includes:
i. a peripheral portion (110) having a pre-defined diameter, the peripheral portion (110) includes a first row (111) of first angled struts (111a) disposed either at the proximal end (100a) and the distal end (100b), and a second row (113) of second angled struts (113a) coupled to the first row (111) of first angled struts (111a) via a plurality of first links (117),
ii. a middle portion (130) disposed adjacent to the peripheral portion (110) and coupled thereto via a plurality of second links (133),
• wherein the diameter of the middle portion (130) reduces from a maximum diameter at the peripheral portion (110) to a minimum diameter,
• the middle portions (130) include at least one row of connectors (131a), the connectors (131a) having two elongated stems ‘g’ and two flared arms ‘h’, the flared arms ‘h’ of each of the connector (131a) are coupled to alternate pairs of second angle struts (113a) of the second row (113) via the second links (133);
d. a plurality of studs (137) coupling the stems ‘g’ of the connector (131a) of the proximal portion (101) to respective stems ‘g’ of an adjacently disposed connector (131a) of the distal portion (103), thereby coupling the middle portions (130) of the proximal portion (101) and the distal portion (103);
wherein, the pre-defined diameter of the peripheral portions (110) of the proximal portion (101) and the distal portion (103) is the same.
2. The implant (100, 200, 300) as claimed in claim 1, wherein the pre-defined diameter of the peripheral portions (110) ranges from 5 mm to 15 mm.
3. The implant (100, 200, 300) as claimed in claim 1, wherein the minimum diameter of the middle portion (130) ranges from 2 mm to 6 mm.
4. The implant (100, 200, 300) as claimed in claim 1, wherein the length of the first angled struts (111a) is larger than the length of the second angled struts (113a).
5. The implant (100, 200, 300) as claimed in claim 1, wherein the diameter of the middle portions (130) either gradually or abruptly tapers from the maximum diameter at the peripheral portion (110) to the minimum diameter.
6. The implant (100, 200, 300) as claimed in claim 1, wherein the adjacently disposed flared arms ‘h’ of two adjacently disposed connectors (131a) are coupled to each other via at least one first linking strut (139a).
7. The implant (100, 200, 300) as claimed in claim 6, wherein the width of the first linking strut (139a) is relatively less than the width of the connector (131a).
8. The implant (100, 200, 300) as claimed in claim 6, wherein the width of the first linking struts (139a) ranges from 0.05 mm to 1.5 mm.
9. The implant (300) as claimed in claim 6, wherein at least one first linking strut (339a) of the proximal portion (301) is coupled to at least one first linking strut (339a) of the distal portion (303), which is adjacently disposed to the at least one first linking strut (339a) of the proximal portion (301), via one or more second linking struts (339b).
10. The implant (100, 200, 300) as claimed in claim 1, wherein the peripheral portions (110) of at least one of the proximal portion (101) and the distal portion (103) includes one or more eyelets (115) configured to receive at least one radiopaque marker.
11. The implant (100, 200, 300) as claimed in claim 1, wherein at least one of the connectors (131a) is provided with a nested connector (131b) defining two stems ‘j’ and flared tips ‘k’.
12. The implant (200) as claimed in claim 11, wherein the stems ‘j’ of each of the nested connector (231b) is coupled to the stems ‘g’ of the respective connector (231a) via a linking strut (231c).
13. An implant (100, 200, 300) comprising:
a. a proximal end (100a) and a distal end (100b);
b. a proximal portion (101) disposed at the proximal end (100a); and
c. a distal portion (103) disposed at the distal end (100b), each of the proximal portion (101) and the distal portion (103) includes:
i. a peripheral portion (110) having a pre-defined diameter, the peripheral portion (110) includes at least two rows of circumferentially arranged angled struts coupled to each other via a plurality of first links (117),
ii. a middle portion (130) disposed adjacent to the peripheral portion (110) and coupled thereto via a plurality of second links (133),
• wherein the diameter of the middle portion (130) reduces from a maximum diameter at the peripheral portion (110) to a minimum diameter,
• the middle portions (130) include at least one row of connectors (131a) coupled to one row circumferentially arranged angled struts from the at least two circumferentially arranged angled struts of the peripheral portion (110) via the second links (133), the connectors (131a) having two elongated stems ‘g’ and two flared arms ‘h’, and
iii. at least one first linking strut (139a) coupling the adjacently disposed flared arms ‘h’ of two adjacently disposed connectors (131a); and
d. a plurality of studs (137) coupling the stems ‘g’ of the connector (131a) of the proximal portion (101) to respective stems ‘g’ of an adjacently disposed connector (131a) of the distal portion (103), thereby coupling the middle portions (130) of the proximal portion (101) and the distal portion (103);
wherein, the pre-defined diameter of the peripheral portions (110) of the proximal portion (101) and the distal portion (103) is the same.
14. The implant (100, 200, 300) as claimed in claim 13, wherein the connectors (131a) are Y-shaped.
15. The implant (100, 200, 300) as claimed in claim 13, wherein the adjacently disposed flared arms ‘h’ of two adjacently disposed connectors (131a) are coupled to each other via two first linking strut (139a) in an X-like arrangement.