Description:FIELD OF THE INVENTION
The present invention relates to the flow diversion technique for treating aneurysms by placing a stent in blood vessel. More specifically, it refers to a flow regulator device featuring parallel strand wire design disclosing a flow diverter with a braided mesh in which each strand comprises two parallel wires instead of a single wire.

BACKGROUND OF THE INVENTION
An excessive localized swelling of the wall of an artery also referred to as an aneurysm, can be a nidus (starting point) for clot formation (thrombosis) and embolization. As an aneurysm increases in size, the risk of rupture increases, which could lead to uncontrolled bleeding. To avoid aneurysms a flow diversion technique is used, where a stent is placed using a catheter into the blood vessel where an aneurysm has formed. A braided device called flow diverter is used whose primary function is to divert blood flow away from the intracranial aneurysm and change the direction of the blood to normal path of the parent vessels resulting in exclusion of blood flow from aneurysm.
The principle of flow diverter by way of stenting is a procedure where a small mesh-like tube called stent-like is placed in the blood vessel to divert the flow away from the aneurysm. The conventional approach to treating intracranial aneurysms with flow diversion uses a single-wire (nitinol, platinum-core nitinol) braided stent (flow diverter) that is placed across the neck of aneurysm, wherein the traditional single wire stent has high porosity and low metal coverage which allows more blood to enter the aneurysm, reducing the effectiveness of the treatment. It also lacks in radial force and wall apposition due to which poor vessel wall contact is established and also aneurysm sealing is in an incomplete manner, device migration after being placed is also an evident shortcoming of stents used. A major issue with the stent is deployment stability, which results in uneven or unpredictable deployment of the device.
The present invention follows the path of the same principle overcoming the lacunas of the traditional flow diverter by arranging two parallel strand design in place of a single strand within a braided mesh that changes the capacity of device to handle mechanical stress and blood flow interaction resulting in better clinical performance. By using stent made using two parallel strands the mechanical performance improves as the forces are divided along a broader contact area, reducing the stress points, friction and fatigue. The present arrangement makes flow diversion more effective as the braid naturally has lower porosity which disrupts blood flow more efficiently into the aneurysm. The major issue of device stability found in traditional flow diverter is solved by the present invention, as the structural arrangements conforms better to the vessel wall and resists unwanted movement. This design achieves these benefits without increasing the overall number of strands or making the device larger, preserving deliverability through existing medical catheters.
Prior Art:
For instance, US11911302B2 improves radial strength and kink resistance by using a set of thicker wires in specific inter-braiding patterns. It does not disclose two parallel filaments acting as a single structural element within the braid. The mechanical and functional properties of our invention arise from the parallel-strand braid design, which ensures uniform stress distribution, reduced inter-wire friction, optimal porosity of 60–76%, and metal coverage between 40–45%, which is not addressed here.
DE102012020849A1 discloses parallel filaments arranged at a defined spacing and connected at their ends using cuffs. It does not disclose coaxially aligned parallel strands functioning as a single unified wire within the braid. The structural and mechanical advantages in our invention arise from the parallel strand acting as one wire, enabling linear surface contact, minimized friction, uniform stress distribution, and optimized porosity and pore density, which is not addressed here
US20230263529A1 focuses on the delivery and deployment system for self-expanding neurovascular flow diverters with radiopaque and mechanical features to aid placement. It does not specify or claim a mesh braid incorporating two parallel metal strands per wire. The mechanical performance improvements in our invention arise from the parallel configuration ensuring linear contact between wires, minimizing localized mechanical stresses and promoting uniform surface and pressure distribution, which is not addressed here.
US12053183B2 shares the same emphasis on delivery features and handling during placement for self-expanding neurovascular flow diverters. It does not disclose two parallel strands braided into a tubular mesh wherein said strands are coaxially aligned along the longitudinal axis of the device. The performance advantages in our invention arise from the parallel-strand braid configuration, which reduces wear, increases stability under pressure, improves resistance to axial movements, and enhances fatigue resistance due to decreased inter-wire friction, which is not present here.
Although the existing systems do provide braided flow diverters for neurovascular applications, they lack in the structural and functional parameters. The present invention incorporates two parallel strands acting as a single structural element within the braid, coaxially aligned along the device’s longitudinal axis. This configuration ensures linear surface contact between wires, uniform stress distribution, minimized inter-wire friction, and enhanced fatigue resistance. Furthermore, it enables optimized porosity and metal coverage, delivering improved radial strength, stability under pressure, and superior flow diversion performance without the added bulk or complexity of overlays, or thicker wire sets

DEFINITIONS
The expression “buddy-wire” used hereinafter in this specification refers to synergistic wire interaction which resolves crucial technical issues found in single-wire.
The expression “uniform deployment” used hereinafter in this specification refers to the consistent and effective placement of the device during medical procedures.
The expression “endothelialisation” used hereinafter in this specification refers to the process where specialized cells restore the endothelium to maintain the health of the circulatory system.
The expression “cranial aneurysm” used hereinafter in this specification refers to bulge or ballooning in the weak area of the artery in the brain.
The expression “braid mesh” used hereinafter in this specification refers to the method of interlacing two or more strands of wire to create a flexible structure.
The expression “linear contact between wires” used hereinafter in this specification refers to the parallel strands that enable perfect alignment of wire layers to minimize localized stresses under load.
The expression “aneurysm occlusion” used hereinafter in this specification refers to the procedure that is used to block blood flow into an aneurysm which can cause life threatening bleeding.

OBJECT OF THE INVENTION
The primary object of the present invention is to provide a flow regulator device featuring parallel strand wire design.
Another object of the present invention is to provide a device that accelerates endothelialisation across the aneurysm neck, which facilitates vessel healing and remodeling.
Another object of the invention is to provide a superior mechanical performance and improved hemodynamic and clinical outcomes compared to traditional single-wire designs.
A further object of the invention is to resolve crucial issues found in classical single-wire flow diverters, such as high porosity, loose braiding mesh at ends, and migration risk due to low radial force.
Yet another object is to act as a scaffold for endothelial cell growth across the aneurysm neck, facilitating vessel healing and remodeling.
Yet a next object is to improve mechanical and deployment characteristics, potentially enhancing clinical outcomes and minimizing complications.

SUMMARY OF THE INVENTION
Before the present invention is described, it is to be understood that the present invention is not limited to specific methodologies and materials described, as these may vary as per the person skilled in the art. It is also to be understood that the terminology used in the description is for the purpose of describing the particular embodiments only and is not intended to limit the scope of the present invention.
The present invention a flow regulator device featuring parallel strand wire design designed for correcting intracranial aneurysms through a novel braided mesh structure featuring a parallel strand wire design. Unlike traditional monolayer configurations, this device incorporates dual metal strands arranged in an overlapping pattern to form a braided tubular body. The device includes key components such as a tubular braided mesh body with proximal and distal end sections, formed from parallel wire strands that intersect to create junctions. This design enables the redirection of blood flow away from the aneurysm while reconstructing the parent vessel, thereby supporting both aneurysm treatment and vessel repair.
In an aspect, the braided tubular body consists of at least 48 platinum-core nitinol strands, with each wire incorporating two parallel metal filaments; that ensures linear contact at crossover points, thereby minimizing localized stress and evenly distributing pressure across the device. The device also demonstrates excellent mechanical performance, including stable deployment with 100% size recovery, minimized torsional and axial stress, and a high radial force of approximately 5.0 gf. Furthermore, it achieves a metal coverage of 40–45% and pore density of ≥30 pores/mm², resulting in optimal porosity (60–76%) for enhanced flow disruption and aneurysm occlusion and exclusion from the flow circulation.
In yet another aspects, the invention offers advantages including; the dual-strand mesh braid enhances radial force for improved wall apposition and provides the flexibility needed to conform to complex vascular anatomies. Its optimized porosity ensures effective flow diversion while reducing microcatheter friction due to a lower trackability force. The design minimizes inter-wire friction, increasing device longevity and reducing wear and tear. The device further prevents migration and deformation under pressure, promoting intra-aneurysmal thrombosis and rapid endothelialization, ultimately leading to successful aneurysm exclusion and vessel healing.

BRIEF DESCRIPTION OF DRAWINGS
A comprehensive understanding of the present invention may be achieved by referring to the following detailed description, which should be read in conjunction with the accompanying drawing. The drawing, which forms an integral part of this specification, provides a visual representation of the invention and, together with the description, elucidates its construction, operation, and key functional aspects
Fig.1 Illustrates the flow regulator device with a parallel mesh braid structure created by double filament strands.
Fig.2 Illustrates cross section of the mesh braid structure.
Fig.3 Illustrates axial view of the mesh braid structure
Fig.4 Illustrates the lateral view of the device
Fig.5 Illustrates cross braiding of the strands (enlarged)
Fig .6 Illustrates junction of wires
Fig.7 Illustrated the enlarged view of junction of wires

DETAILED DESCRIPTION OF THE INVENTION
Before the present invention is described, it is to be understood that this invention is not limited to methodologies described, as these may vary as per the person skilled in the art. It is also to be understood that the terminology used in the description is for the purpose of describing the particular embodiments only and is not intended to limit the scope of the present invention. Throughout this specification, the word “comprises”, or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps. The use of the expression “at least” or “at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the invention to achieve one or more of the desired objects or results. Various embodiments of the present invention are described below. It is, however, noted that the present invention is not limited to these embodiments, but rather the intention is that modifications that are apparent are also included.
The present invention discloses a flow regulation device featuring parallel strand wire design which relates to an aneurysm flow regulator comprising of mesh braid incorporating dual metal strands arranged in an interlaced manner to form a junction thereby replacing conventional monolayer arrangement which ensures linear contact between strands resulting in minimizing localized mechanical stress and create uniform surface and pressure distribution. The present device facilitates aneurysm treatment and parent vessel reconstruction. The novel configuration reduces wear, extends device life, enhances pressure stability, and improves fatigue resistance by minimizing inter-wire friction.
The invention relates to a flow regulator device [100], designed as a braided endovascular implant for the treatment of intracranial aneurysms. The device [100] comprises a tubular body [102] formed of parallel wire strands [103] arranged in a braided mesh, with a proximal end section [101a] and a distal end section [101b] that secure the structure, as illustrated in Figs. 1–7. The parallel wire strands cross over each other to form a mesh-like structures; the joints where these two strands cross is called a junction [104] Together, these components allow the device to divert blood flow away from an aneurysm, promote intra-aneurysmal thrombosis, and reconstruct the parent vessel.
The device consists of: -
No. Components
100 Flow regulator device
102 Braided mesh tubular body [102]
101a/101b proximal end section [101a] and a distal end section [101b]
103 Parallel wire strand [103]
104 Junction or crossover point
In an embodiment the braided mesh tubular body [102] consists approximately of 48 strands, made up of platinum-core nitinol that incorporate two parallel metal strands per wire, arranged in a manner that provide linear contact between wires at the crossover point or junction [104]. This configuration minimizes localized mechanical stresses and aids with uniform surface and pressure distribution across the device. The device [100] also provides a trackability force of 11–22 gf (0.11–0.22 N) within microcatheters, facilitating smoother navigation. Deployment is stable, with the device achieving 100% size recovery and avoiding end-mesh loosening.
In another embodiment the dual strand design is made with a proximal end section [101a] and a distal end section [101b] enhances stability under pressure extending the functionality of the device for longer life span. It further contributes in eliminating torsional stresses and improving the resistant to axial movements. The dual strand maintains the structural integrity by reducing inter wire friction and increasing fatigue resistance, functionally higher metal coverage results in decreased porosity which causes rapid intra aneurysmal thrombosis by disrupting the flow of blood effectively in aneurysm, which catalyzes the process of endothelialization across the aneurysm neck. In the present invention, the dual filament strands confer greater radial force, measured at approximately 5.0 gf which is significantly higher than the conventional single wire configuration, the balanced radial force ensures improved wall apposition and conforms to tortuous vessel walls. The deployment of the device via microcatheter in artery is streamlined due to reduced friction which explicitly enhances the deliverability.
In another embodiment, the parallel wire strand [103] provides linear surface contact between wires, so that the present arrangement distributes stress uniformly over device and minimizes wear. Due to reduced torsional stress the stability of device is improved thereby preventing crack propagation and extending the functional lifespan of the device. The metal coverage increases due to dual parallel design to 40% and 45 % and reduces porosity into the optimal range of 60-76% This structure exhibiting greater pore density approximately ≥30 pores/mm² thereby enhancing flow disruption at the aneurysm neck. This promotes rapid intra aneurysmal thrombosis and faster aneurysm occlusion. The device also enables intra-aneurysmal stasis and subsequent thrombus formation, leading to aneurysm exclusion from circulation.
Advantages:
The present invention provides various functional and clinical advantages including:
1. The mesh braid structure provides balanced radial force optimize for outward force for secure wall apposition.
2. The flexibility attained via incorporating the double wire design allows device to adapt to tortuous neurovascular anatomy.
3. The double strand arrangement maintains ideal porosity range for effective flow diversion and aneurysm occlusion.
4. Reduced trackability force due to parallel strand design lowers the friction inside microcatheters.
5. The uniform pore distribution enhances flow disruption at the aneurysm neck.
6. The present device has a reduced axial deformation and prevents device migration as it has enhanced stability.
7. The enhanced hemodynamic aneurysmal thrombosis and endothelialization.

While considerable emphasis has been placed herein on the specific elements of the various embodiments, it will be appreciated that many alterations can be made and that many modifications can be made in the various embodiments without departing from the principles of the invention. These and other changes in the various embodiments of the invention will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation.
, Claims:CLAIMS:
1. A flow regulation device featuring parallel strand wire design; wherein the flow regulator device [100] comprising a tubular body [102] formed of parallel wire strands [103] arranged in a braided mesh, with a proximal end section [101a] and a distal end section [101b] that secure the structure, where the parallel wire strands cross over each other to form a junction [104];

characterized in that:
the device is a braided aneurysm flow regulator, endovascular implant for intracranial aneurysms, wherein each mesh braid incorporates dual metal strands [103] arranged in an interlaced manner to form a junction [104] ensuring linear contact between strands [103] resulting in minimizing localized mechanical stress and creating uniform surface and pressure distribution;
the dual metal strands [103] maintain the structural integrity by reducing inter wire friction and increasing fatigue resistance; and
functionally higher metal coverage results in decreased porosity causing rapid intra aneurysmal thrombosis by disrupting the flow of blood effectively in aneurysm, thereby catalyzing the process of endothelialization across the aneurysm neck; and
allowing the device [100] to divert blood flow away from an aneurysm, and promote intra-aneurysmal thrombosis, facilitate aneurysm correction and reconstruct the parent vessel.

2. The device as claimed in claim 1, wherein the configuration of the device [100] reduces wear, extends device life, enhances pressure stability, and improves fatigue resistance by minimizing inter-wire friction.

3. The device as claimed in claim 1, wherein the braided mesh tubular body [102] consists of 48 strands made up of platinum-core nitinol that incorporate two parallel metal strands per wire, arranged in a manner that provide linear contact between wires at the crossover point or junction [104].

4. The device as claimed in claim 1, wherein the device [100] provides a trackability force of 11–22 gf (0.11–0.22 N) within microcatheters, facilitating smoother navigation; wherein the deployment is stable, with the device achieving 100% size recovery and avoiding end-mesh loosening.

5. The device as claimed in claim 1, wherein the proximal end section [101a] and the distal end section [101b] of the dual strand enhances stability under pressure extending the functionality of the device for longer life span; eliminates torsional stresses and improves the resistant to axial movements.

6. The device as claimed in claim 1, wherein the dual metal strands [103] confer greater radial force measured at 5.0 gf such that the balanced radial force ensures improved wall apposition and conforms to tortuous vessel walls; wherein the deployment of the device [100] via microcatheter in artery is streamlined due to reduced friction which explicitly enhances the deliverability.

7. The device as claimed in claim 1, wherein the metal coverage increases due to dual parallel design to 40% and 45 % and reduces porosity into the optimal range of 60-76%; exhibiting greater pore density of approximately ≥30 pores/mm² thereby enhancing flow disruption at the aneurysm neck.