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FORM 2
THE PATENTS ACT, 1970 (39 OF1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
[SEE SECTION 10, RULE 13]
STENT HAVING MULTIPLE BRIDGING JUNCTIONS
BIORAD MEDISYS PRIVATE LIMITED
AN INDIAN COMPANY HAVING OFFICE ADDRESS AT
Survey No. 48, 3 & 48 7, Pashan - Sus Rd, Sus, Pune,
Maharashtra 411021
THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED
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FIELD OF THE INVENTION
[0001]
The present invention generally relates to medical devices for supporting, maintaining, or repairing a lumen, passageway or opening in a living body. In particular, the invention relates to particular intravascular stents, which are adapted 5 to be implanted into a patient's body lumen, such as a blood vessel or coronary artery, to maintain the patency thereof.
BACKGROUND
[0002]
Carotid artery stenosis is a condition where the carotid arteries, which supply blood to the brain, become narrowed or blocked due to plaque buildup. This 10 can reduce blood flow to the brain and increase the risk of stroke. One of the treatments for carotid artery stenosis is carotid stenting which involves inserting a mesh tube (stent) into the vessel to serve as a scaffold that helps prevent the artery from narrowing again. A stent is a well-known medical scaffolding device that is often tubular that is used for maintaining the patency of a large variety of lumens 15 of the human body. Modern intravascular stents are available in balloon-expandable and self-expanding varieties. In both of these classes, stents have been made by different techniques, including forming from wire and machining from a hollow tube. Such machining can be done by photo-chemical etching, laser-cutting, stamping, piercing, or other material-removal processes. Other manufacturing 20 techniques have been proposed, such as vacuum or chemical deposition of material or forming a tube of machined flat material, but those “exotic” methods have not been widely commercialized.
[0003]
To overcome these limitations and drawbacks, a need is recognized for an implantable prosthesis device that maintains the patency of a vessel with the ability 25 to adapt to the tortuous anatomy of the host by being highly flexible and highly durable while being loadable into a delivery catheter of sufficiently small profile
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and easily deliverable to a target site in the vessel or duct by having the ability to
navigate tortuous ducts or vessels.
[0004]
This invention is therefore directed towards providing an effective vascular implant, which is relatively simple in design and structure, and is highly effective for its intended purpose. 5
SUMMARY
[0005]
Embodiment of the present disclosure present technological improvements as solutions to one or more of the above-mentioned technical problems recognized by the inventor(s) in conventional systems. 10
[0006]
The present invention discloses an intravascular stent. The stent comprising a plurality of circular structure. The plurality of circular structure comprises a first structure and a second structure. The first structure and the second structure is made up of plurality of peaks and valleys to form an undulating pattern. The undulating pattern of the first structure and the second structure is mirror to each other. The 15 plurality of circular structure further comprises a plurality of links. The plurality of links are coupled in between the plurality of the valleys. The plurality of circular structure are coupled with the plurality of links to form a radially expandable stent.
[0007]
It will be appreciated that features of the present disclosure are susceptible to being combined in various combinations without departing from the scope of the 20 present disclosure as defined by the detailed description and drawings below.
BRIEF DESCRIPTION OF THE FIGURES
[0008]
The summary above, as well as the following detailed description of illustrative embodiment, is better understood when read in conjunction with the 25
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appended drawings.
For illustrating the present disclosure, example constructions of the disclosure are shown in the drawings. However, the present disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in art will understand that the drawings are not to scale. Wherever possible, like elements have been indicated by identical numbers. 5
[0009]
Embodiment of the present disclosure will now be described, by way of example only, with reference to the following diagrams wherein:
[0010]
Fig 1 illustrates a illustrates a flat layout view of stent in accordance with an exemplary embodiment of the present disclosure;
[0011]
Fig. 2 illustrates a perspective view of a stent in accordance with an 10 exemplary embodiment of the present disclosure;
[0012]
In the above accompanying drawings, a number relates to an item identified by a line linking the number to the item. When a number is accompanied by an associated arrow, the number is used to identify a general item at which the arrow is pointing. 15
[0013]
Further the figures depict various embodiment of the present subject matter for purposes of illustration only. One skilled in the art will readily recognize from the following discussion that alternative embodiment of the structures and methods illustrated herein may be employed without departing from the principles of the present subject matter described herein. 20
DETAILED DESCRIPTION OF EMBODIMENTS
[0014]
The following detailed description illustrates embodiment of the present disclosure and manners by which they can be implemented. The words "comprising," "having," "containing," and "including," and other forms thereof, are 25 intended to be equivalent in meaning and be open ended in that an item or items
5
following any one of these words is not meant to be an exhaustive listing of such
item or items, or meant to be limited to only the listed item or items. It must also be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. 5
[0015]
The person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure. It should be understood that this invention is not limited to the particular methodology, protocols, and the like, described herein and as such may vary. The terminology used herein is for the purpose of describing particular embodiment only and is not 10 intended to limit the scope of the present invention, which is defined solely by the claims. Various modifications, however, will remain readily apparent to those skilled in the art, since the generic principles of the present invention have been defined herein specifically to provide an intravascular stent.
[0016]
The present disclosure provides technical solutions to the technical 15 problems identified in the prior art. In the prior art, the great majority of stents delivered trans luminally and percutaneously to a stenting site in a human body are made of a biologically compatible material which is a metal. Many stents are made of stainless steel, and many others are made of nickel titanium shape memory alloy. The nickel titanium stents are invariably self-expanding stents that utilise a shape 20 memory effect for moving between a radially compact transluminal delivery disposition and a radially larger stenting disposition after placement in the body. However, conventional stents may have drawbacks such as low flexibility, high radial force, poor wall apposition, and susceptibility to fatigue fracture. Fatigue fracture is a failure mode of stents that occurs when they are subjected to repeated 25 mechanical stress cycles at the deployment site in the body lumen. Fatigue fracture can compromise the structural integrity and functionality of the stent and lead to adverse outcomes such as restenosis, thrombosis, or embolization.
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[0017]
Self-expanding stents are usually manufactured in a ready-to-use compressed form within a catheter-based sheath that functions as a delivery system. Typically, stents are implanted within a passageway by positioning the stent within the area to be treated and then expanding the stent from a compressed diameter to an expanded diameter. The ability of the stent to expand from a compressed 5 diameter makes it possible to thread the stent to the area to be treated through various narrow body passageways while the stent is in the compressed diameter. Once the stent has been positioned and expanded at the area to be treated, the tubular support structure of the stent contacts and radially supports the inner wall of the passageway. As a result, the implanted stent mechanically prevents the 10 passageway from closing and keeps the passageway open to facilitate fluid flow through the passageway.
[0018]
The present invention is related to a stent. The stent comprising a plurality of circular structure. The plurality of circular structure comprises a first structure and a second structure. The first structure and the second structure is made up of 15 plurality of peaks and valleys to form an undulating pattern. The undulating pattern comprises a thickness range between 0.8 mm to 2 mm. The undulating pattern of the first structure and the second structure is mirror to each other. The plurality of circular structure further comprises a plurality of links. The plurality of links are coupled in between the plurality of the valleys. The length of the link ranges 20 between 40 mm to 80 mm. The plurality of circular structure are coupled with the plurality of links to form a radially expandable stent.
[0019]
The stent comprises a first dimeter in contracted mode. The first diameter of the stent in contracted mode is varies from 3 mm to 5 mm. The stent comprises a second dimeter in expanded condition. The second diameter of the stent in 25 expandable mode is varies from 10 to 14 mm. A high visibility radiopaque tantalum markers are provided at the proximal and distal end of the stent.
[0020]
The present invention provides a vascular implant that has high resistance to fracture when mechanically cycled at a site in a body lumen.
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[0021]
The present invention provides a stent having a high degree of flexibility so that it can be advanced through tortuous passageways and can be readily expanded.
[0022]
The invention provides a stent that exhibits good strength while having the ability to follow the contour of the vessel within which it is implanted.
[0023]
The present invention proposes a fatigue fracture resistant vascular implant, 5 such as a self-expanding stent designed to address the limitations of existing stent designs. The stent is constructed with a unique spiral cell connection pattern, enhancing its flexibility and allowing for controlled expansion and contraction. This innovative design reduces stress concentrations and minimizes the risk of fatigue-induced fractures. The stent design is optimized to resist compression 10 forces while maintaining excellent apposition against the luminal wall. This ensures stable deployment at the site of obstruction, preventing vessel collapse and maintaining an open lumen. The stent incorporates a peak-to-peak nodes connection mechanism, which efficiently disperses mechanical forces across the entire stent structure. This feature contributes to the implant's overall mechanical 15 integrity and fracture resistance.
[0024]
It should be noted that the above advantages and other advantages will be better evident in the subsequent description. Further, in the subsequent section, the present subject is better explained with reference to the figures. In order to maintain consistency and brevity of reading, the all the figures from 1 and 2 are explained 20 jointly. Further, the following table lists of nomenclature and numberings are used in the figure to illustrate the invention and the nomenclature is further used to describe in the invention the subsequent paragraph.
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Number
Nomenclature
Number
Nomenclature
100
Stent
106
Undulating pattern
102
plurality of circular structure
108
Plurality of peaks
103
First structure
109
Plurality of valleys
104
Plurality of links
202
High visibility radiopaque tantalum markers
105
Second structure
[0025]
Referring now to the drawings, Figures. 1-2 illustrates Intraluminal Medical Device having High Fatigue Resistance. It should be noted that Figure 1-2 are merely examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiments of the present disclosure. 5
[0026]
Referring now to the drawings, figure 1, an embodiment of a stent 100 according to the present invention is shown. The stent 100 comprising a plurality of circular structure 102. The plurality of circular structure 102 comprises a first structure 103 and a second structure 105. The first structure 105 and the second structure 103 is made up of plurality of peaks and valleys to form an undulating 10 pattern 106. The undulating pattern 106 comprises a thickness range between 0.8 mm to 2 mm. The undulating pattern 106 of the first structure 103 and the second structure 105 is mirror to each other. The plurality of circular structure 102 further comprises a plurality of links 104. The plurality of links 104 are coupled in between the plurality of the valleys 109. The length of the link 104 ranges between 40 mm 15 to 80 mm. The plurality of circular structure 102 are coupled with the plurality of links 104 to form a radially expandable stent 100.
[0027]
The stent 100 comprises a first dimeter in contracted mode. The first diameter of the stent 100 in contracted mode is varies from 3 mm to 5 mm. The stent 100 comprises a second dimeter. The second diameter of the stent 100 in 20 expandable mode is varies from 10 to 14 mm. A high visibility radiopaque tantalum markers 202 are provided at the proximal and distal end of the stent 100.
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[0028]
The plurality of circular structure 102 includes undulating pattern 106 that are advantageously designed that may provide characteristics that can be expanded/bent without causing substantial damage to the stent and is joined to an adjacent circular structure by a coupling plurality of links 104 to form a radially expandable stent 100. 5
[0029]
The height value H may be between about 40-80 mm. The stent 100 has undulating pattern 106 having a thickness of about 0.8 - 2 mm that provides outward radial force. The stent 100 has a full diameter of about 12 mm and can crimp down to about 5 mm or less (not shown).
[0030]
The present invention provides a vascular implant that has high resistance 10 to fracture when mechanically cycled at a site in a body lumen.
[0031]
The present invention provides a stent 100 having a high degree of flexibility so, that it can be advanced through tortuous passageways and can be readily expanded.
[0032]
The invention provides a stent 100 that exhibits good strength while having 15 the ability to follow the contour of the vessel within which it is implanted.
[0033]
The present invention proposes a fatigue fracture resistant vascular implant, such as a self-expanding stent designed to address the limitations of existing stent 100 designs. The stent 100 is constructed with a unique spiral cell connection pattern, enhancing its flexibility and allowing for controlled expansion and 20 contraction. This innovative design reduces stress concentrations and minimizes the risk of fatigue-induced fractures. The stent 100 design is optimized to resist compression forces while maintaining excellent apposition against the luminal wall. This ensures stable deployment at the site of obstruction, preventing vessel collapse and maintaining an open lumen. The stent 100 incorporates a peak-to-peak 25 nodes connection mechanism, which efficiently disperses mechanical forces across the entire stent 100 structure. This feature contributes to the implant's overall mechanical integrity and fracture resistance.
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[0034]
Figure 2 illustrates a perspective view of a stent 100 in accordance with an exemplary embodiment of the present disclosure The undulations are shaped into a plurality of full-circle sections. The plurality of the circular structures 102 are coupled with the plurality of links 104 to form a radially expandable stent 100.
[0035]
Fig. 1-2 are merely examples. A person skilled in the art will recognize 5 many variations, alternatives, and modifications of the embodiment of the present disclosure.
[0036]
While a particular embodiment of the invention has been illustrated and described, modifications thereof will readily occur to those skilled in the art. It is understood that the various embodiment, details and constructions of the stent and 10 their features described above and illustrated in the attached figures may be interchanged among the various embodiment while remaining within the scope of the invention. Additionally, it is understood that various modifications could be made to any of the elements described herein above while remaining within the scope of the invention. 15

We Claim:

1. A stent (100), wherein the stent (100) comprising:
a plurality of circular structure (102), wherein the plurality of circular structure (102) comprises: 5
a first structure (103) and a second structure (105), wherein the first structure (105) and the second structure (103) is made up of a plurality of peaks (108) and a plurality of valleys (109) to form an undulating pattern (106), wherein the undulating pattern (106) of the first structure (103) and the second structure (105) is mirror to 10 each other; and
a plurality of links (104), wherein the plurality of links (104) are coupled in between the plurality of the valleys (109); and
wherein the plurality of circular structure (102) are coupled with the plurality of links (104) to form a radially expandable stent (100). 15

2.The stent as claimed in claim 1, wherein high visibility radiopaque tantalum markers (202) are provided at the proximal and distal end of the stent (100).

3.The stent as claimed in claim 1, wherein the length of the link (104) ranges between 40 mm to 80 mm. 20

4.The stent as claimed in claim 1, wherein the undulating pattern (106) comprises a thickness range between 0.8 mm to 2 mm.

5.The stent as claimed in claim 1, wherein the stent (100) comprises a first dimeter 25 in contracted condition, wherein the first diameter of the stent (100) in contracted condition is varies from 3 mm to 5 mm.

6.The stent as claimed in claim 1, wherein the stent (100) comprises a second diameter in expandable condition, wherein the second diameter of the stent (100) in expandable condition is varies from 10 to 14 mm.

Dated this on,
25th Day of August, 2024