1
FORM 2
THE PATENTS ACT, 1970 (39 OF1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
[SEE SECTION 10, RULE 13]
INTRALUMINAL MEDICAL DEVICE HAVING HIGH FATIGUE RESISTANCE
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
2
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
3
durable
while being loadable into a delivery catheter of sufficiently small profile 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 5 for its intended purpose.
SUMMARY
[0005]
Embodiment of the present disclosure present technological improvements as solutions to one or more of the above-mentioned technical problems recognized 10 by the inventor(s) in conventional systems.
[0006]
The present invention discloses a 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 15 pattern of the first structure and the second structure is mirror to each other. The undulating pattern comprises a plurality of first peaks and a plurality of second peaks. A height of the plurality of second peaks is less than the plurality of first peak. The plurality of second peaks and the plurality of first peaks are alternate. The plurality of circular structure further comprises a plurality of links. The 20 plurality of links are coupled in between the plurality of second peaks of the first structure and second structure. The plurality of circular structures are connected at the plurality of first peak 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 25 present disclosure as defined by the detailed description and drawings below.
4
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 appended drawings. For illustrating the present disclosure, example constructions 5 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.
[0009]
Embodiment of the present disclosure will now be described, by way of 10 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 exemplary embodiment of the present disclosure; 15
[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.
[0013]
Further the figures depict various embodiment of the present subject matter 20 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.
25
5
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 5 intended to be equivalent in meaning and be open ended in that an item or items 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 10 otherwise.
[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 15 used herein is for the purpose of describing particular embodiment only and is not 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. 20
[0016]
The present disclosure provides technical solutions to the technical 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. 25 The nickel titanium stents are invariably self-expanding stents that utilise a shape memory effect for moving between a radially compact transluminal delivery
6
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 mechanical stress cycles at the deployment site in the body lumen. Fatigue fracture 5 can compromise the structural integrity and functionality of the stent and lead to adverse outcomes such as restenosis, thrombosis, or embolization.
[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 10 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 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 15 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 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 20 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 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 undulating 25 pattern comprises a plurality of first peaks and a plurality of second peaks. A height of the plurality of second peaks is less than the plurality of first peak. The plurality of second peaks and the plurality of first peaks are alternate. The plurality of circular structure further comprises a plurality of links. The plurality of links are coupled in between the plurality of second peaks of the first structure and second 30
7
structure. The length of the link varies between 40 mm to 80 mm. The plurality of
circular structures are connected at the plurality of first peak to form a radially expandable stent.
[0019]
A high visibility radiopaque tantalum markers are provided at a proximal and a distal end of the stent. The stent comprises a first dimeter in contracted 5 condition. The first diameter of the stent in contracted condition is varies from 3 mm to 5 mm. The stent comprises a second dimeter in expanded condition, wherein the second diameter of the stent in expanded condition is varies from 10 mm to 14 mm.
[0020]
The present invention provides a vascular implant that has high resistance 10 to fracture when mechanically cycled at a site in a body lumen.
[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. 15
[0023]
The present invention proposes a fatigue fracture resistant vascular implant, 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 20 fatigue-induced fractures. The stent 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 incorporates a peak-to-peak nodes connection mechanism, which efficiently disperses mechanical forces across the 25 entire stent structure. This feature contributes to the implant's overall mechanical integrity and fracture resistance.
8
[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 jointly. Further, the following table lists of nomenclature and numberings are used in 5 the figure to illustrate the invention and the nomenclature is further used to describe in the invention the subsequent paragraph.
Number
Nomenclature
Number
Nomenclature
100
Stent
106
Undulating pattern
102
Plurality of circular structure
108
Plurality of first peaks
103
First structure
110
Plurality of second peaks
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 10 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.
[0026]
Referring now to the drawings, figure 1, an embodiment of a stent 100 according to the present invention is shown. A stent 100 comprising a plurality of 15 circular structure 102. The plurality of circular structure 102 comprises a first structure 103 and a second structure 105. The first structure 103 and the second structure 105 is made up of plurality of peaks and valleys to form an undulating 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 20 structure 105 is mirror to each other. The undulating pattern 106 comprises a plurality of first peaks 108 and a plurality of second peaks 110. A height of the plurality of second peaks 110 is less than the plurality of first peak 108. The
9
plurality of second peaks 110 and the plurality of first peaks 108 are alternate. 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 second peaks 110 of the first structure 103 and second structure 105. The length of the link 104 varies between 40 mm to 80 mm. The plurality of circular structures 102 are connected at 5 the plurality of first peak 108 to form a radially expandable stent 100.
[0027]
Each 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 connecting first peak 108. 10
[0028]
A high visibility radiopaque tantalum markers 202 are provided at a proximal and a distal end of the stent 100.
[0029]
The stent 100 comprises a first dimeter in contracted condition. The first diameter of the stent in contracted condition is varies from 3 mm to 5 mm. The stent 100 comprises a second dimeter in expanded condition, wherein the second 15 diameter of the stent in expanded condition is varies from 10 mm to 14 mm.
[0030]
The first peaks 108 can be configured to allow the undulating pattern 106 to circumferentially expand and contract to produce radial expansion/contraction of the stent 100 and can contribute to the radial outward force produced by the stent 100. A high visibility radiopaque tantalum marker 202 are provided at the 20 proximal and distal end of the stent 100.
[0031]
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). 25
[0032]
The present invention provides a vascular implant that has high resistance to fracture when mechanically cycled at a site in a body lumen.
10
[0033]
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.
[0034]
The invention provides a stent 100 that exhibits good strength while having the ability to follow the contour of the vessel within which it is implanted. 5
[0035]
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 contraction. This innovative design reduces stress concentrations and minimizes 10 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 nodes connection mechanism, which efficiently disperses mechanical forces across 15 the entire stent 100 structure. This feature contributes to the implant's overall mechanical integrity and fracture resistance.
[0036]
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 20 connected at the plurality of first peak 108 to form a radially expandable stent 100.
[0037]
Fig. 1-2 are merely examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure.
[0038]
While a particular embodiment of the invention has been illustrated and 25 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 their features described above and illustrated in the attached figures may be
11
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.

We Claim:

1.A stent (100), wherein the stent (100) comprising:
a plurality of circular structure (102), wherein the plurality of circular 5 structure (102) comprises:
a first structure (103) and a second structure (105), wherein the first structure (103) and the second structure (105) is made up of plurality of peaks and valleys to form an undulating pattern (106), wherein the undulating pattern (106) of the first structure (103) and 10 the second structure (105) is mirror to each other, wherein the undulating pattern (106) comprises:
a plurality of first peaks (108); and
a plurality of second peaks (110), wherein a height of the plurality of second peaks (110) is less than the plurality of 15 first peak (108), wherein the plurality of second peaks (108) and the plurality of first peaks (110) are alternate;
a plurality of links (104), wherein the plurality of links (104) are coupled in between the plurality of second peaks (110) of the first structure (103) and second structure (105); and 20
wherein the plurality of circular structures (102) are connected at the plurality of first peak (108) to form a radially expandable stent (100).

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

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

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 in contracted condition, wherein the first diameter of the stent in contracted 5 condition is varies from 3 mm to 5 mm.

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

Dated this on,
25th Day of August, 2024 15