Description:FIELD OF THE INVENTION
This invention relates to a process to fabricate bio-scaffold materials for the Varicose Vei
BACKGROUND OF THE INVENTION
Obsessive veins are abnormal and twisted veins often situated at the lower part of your body and twist them. They break down the blood vessels, the most common symptom is that the painful parts swell and thus can cause blood to clot. This symptom becomes a serious problem and affects the performance function, its overall ability, and thus also the life satisfactoriness which comes with older age. The other one is obesity that is a common instance of the disease because of which standing for long hours occurs and blood circulation is affected. Major symptoms due to the varicose veins such as change in skin color viz. pigmentation and ulceration, itching, burning, swelling, aching, cramps and heaviness.
Varicose veins are caused by poorly functioning valves in the veins, and decreased elasticity of the vein wall, allowing pooling of blood within the veins, and their subsequent enlargement. Varicose veins affect up to 40% of adults, and are more common in obese people, and in women who have had more than two pregnancies.
To treat the varicosity there are very few temporary treatments were identified to treat in which sclerotherapy injection, endovenous laser treatment, compression stockings. Sclerotherapy is a less invasive medical skill through which a special solution (sclerosant) is injected directly into the affected vein so that it can be collapsed and reabsorbed by the body. This improves both the cosmetic appearance and symptoms like pain, swelling, and heaviness in the legs. Endovenous Laser Treatment (EVLT) and also operates as endovenous laser ablation for treating varicose veins. Through the application of laser energy doctors take control of faulty veins by heating them and sealing them off to redirect blood to wholesome veins. Patients obtain satisfactory treatment results from this method which surgical teams perform as an alternative to vein stripping procedures for large veins in their legs. Many of the doctors were not suggested this endovenous laser ablation treatment because of the high energy beams may damage the veins. And another temporary solution for the varicosity will be the compression stockings are elastic medical garments specifically designed to apply increasing pressure on the legs thus helping improve blood flow and decrease symptoms of varicose veins. The elastic compression supports blood circulation by stopping venous pooling which minimizes symptoms and deep vein thrombosis risks.
https://doi.org/10.1007/s12262-014-1161-z relates to Varicose veins have a high recurrence rate following surgery. Besides poor surgical technique, majority of these recurrences are attributable to neovascularization after both primary and repeat surgery. Authors have studied the effectiveness of a polytetrafluoroethylene (PTFE) patch interposition between the ligated vein stump and the overlying soft tissue at saphenofemoral junction in decreasing recurrence of varicose veins after initial surgery. Study was conducted on 50 patients of varicose veins with saphenofemoral junction incompetence. Patients were randomly divided into two groups, group A and group B alternately. In group A, standard surgical procedure was done followed by PTFE patch application. In group B, same surgical procedure was applied as in group A, with the exception of PTFE patch application. Patients in both groups were given similar postoperative care. A full venous duplex ultrasound assessment was performed in all the patients postoperatively. Neovascularization was observed in five patients (20 %) of group B, while it was not seen in any of the patients in group A at 1-year follow-up. This difference in neovascularization across the two groups was found to be statistically significant with a p value of 0.0251. Hence, authors concluded that patch saphenoplasty helps in reducing recurrence in varicose veins by decreasing neovascularization at saphenofemoral junction.
https://doi.org/10.1016/j.ejvs.2007.03.019 relates to a total of 27 patients (32 legs) attended for assessment at 6 weeks, 25 patients (30 legs) at 1 year and 27 patients (32 legs) at 2 years. At 6 weeks, seven legs (22%) had an area of cutaneous numbness; all but one had resolved by 1 year. Four legs (13%) developed a groin infection, which required antibiotics, 2 had a groin haematoma and four had a seroma, all of which resolved spontaneously. The overall complication rate was 35% (11 legs), with no statistically significant difference between the groups. Four of 16 legs without a patch and five of 16 legs with a patch developed neovascularisation at the saphenofemoral junction on duplex imaging by two years postoperatively. Two cases of neovascularisation in the patch group and one in the no patch group directly resulted in clinical recurrence (p = 1.0). There was an improvement in patients' AVVSSS two years postoperatively (p < 0.03), that was similar in both groups.

RESEARCH GAP:
None of the prior art indicate above either alone or in combination with one another disclose what the present invention has disclosed. This invention relates to a better solution for the treatment of varicose veins would be the fabrication of biodegradable polymer materials encapsulated with drugs to act as patches. These patches can deliver the drug in a controlled manner, providing long-term treatment for varicose vein issues.
SUMMARY OF THE INVENTION
This summary is provided to introduce a selection of concepts, in a simplified format, that are further described in the detailed description of the invention.
This summary is neither intended to identify key or essential inventive concepts of the invention and nor is it intended for determining the scope of the invention.
To further clarify advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof, which is illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail with the accompanying drawings.
The present application explains how to approach the treatment of varicose veins in a simplistic manner. Rather than going for existing treatment options such as surgery or injections, this invention concentrates on:
Biodegradable Drug Delivery Patches: The main concept is to design patches which are capable of stick to the skin. These will continuously release medication intended for the affected veins for a longer duration.
Specific Materials: Patches are made using a blend of biodegradable polymers such as chitosan, alginate and poly (lactic acid), making it easy for them to decompose.
Targeted Drugs: The patches contain drugs specifically selected for the treatment of varicose veins. These Include Amlodipine, Nifedipine, and Prazosin. These medications serve the purpose of helping in dilation of the veins.
Controlled Release: The construction of the patch will enable slow and gradual release of the enclosed drugs which will improve treatment for patients and reduce possible side effects. In summary, the invention aims at the design of a new treatment option for varicose veins by employing materials and drugs combination for delivery via the skin.
Detailed Description of Invention
The detailed description of various exemplary embodiments of the disclosure is described herein with reference to the accompanying drawings. It should be noted that the embodiments are described herein in such details as to clearly communicate the disclosure. However, the amount of details provided herein is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the present disclosure as defined by the appended claims.
It is also to be understood that various arrangements may be devised that, although not explicitly described or shown herein, embody the principles of the present disclosure. Moreover, all statements herein reciting principles, aspects, and embodiments of the present disclosure, as well as specific examples, are intended to encompass equivalents thereof.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments. As used herein, the singular forms “a",” “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises,” “comprising,” “includes” and/or “including,” when used herein, specify the presence of stated features, integers, steps, operations, elements and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components and/or groups thereof.
It should also be noted that in some alternative implementations, the functions/acts noted may occur out of the order noted in the figures. For example, two figures shown in succession may, in fact, be executed concurrently or may sometimes be executed in the reverse order, depending upon the functionality/acts involved.
In addition, the descriptions of "first", "second", “third”, and the like in the present invention are used for the purpose of description only, and are not to be construed as indicating or implying their relative importance or implicitly indicating the number of technical features indicated. Thus, features defining "first" and "second" may include at least one of the features, either explicitly or implicitly.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which example embodiments belong. It will be further understood that terms, e.g., those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
The current idea is on biodegradable polymer-based drug delivery patches for long-term controlled treatment.

Material and method:
The novelty of this work primarily lies in the development of self-adhesive biodegradable polymer-based patches using chitosan, alginate, and poly(lactic acid). These polymers are encapsulated with swellable drugs such as Amlodipine, Nifedipine, and Prazosin, which target vein dilation. The patches are designed to adhere to the skin and gradually release the drugs in a controlled manner, ensuring prolonged delivery without side effects, tailored to patient-specific needs.
A bio-scaffold material for treating varicose veins;
a biodegradable polymer base comprising chitosan, alginate, and poly(lactic acid)
at least one drug encapsulated within the biodegradable polymer base, wherein the at least one drug is selected from the group consisting of Amlodipine, Nifedipine, and Prazosin which target vein dilation. the bio-scaffold material is configured as a patch for topical application to the skin in which one drug is released from the biodegradable polymer base in a controlled manner.
A process for fabricating a bio-scaffold material for treating varicose veins,
the process forming a biodegradable polymer base from chitosan, alginate, and poly(lactic acid);
encapsulating at least one drug within the biodegradable polymer base, wherein the at least one drug is selected from the group consisting of Amlodipine, Nifedipine, and Prazosin; and forming the biodegradable polymer base into a patch for topical application to the skin.
ADVANTAGES OF THE INVENTION
This invention relates to a better solution for the treatment of varicose veins would be the fabrication of biodegradable polymer materials encapsulated with drugs to act as patches. These patches can deliver the drug in a controlled manner, providing long-term treatment for varicose vein issues.

, Claims:1: A bio-scaffold material for treating varicose veins, comprising:
a biodegradable polymer base comprising chitosan, alginate, and poly(lactic acid); and
at least one drug encapsulated within the biodegradable polymer base, wherein the at least one drug is selected from the group consisting of Amlodipine, Nifedipine, and Prazosin.
2. The bio-scaffold material as claimed in claim 1, wherein the bio-scaffold material is configured as a patch for topical application to the skin.
3. The bio-scaffold material as claimed in claim 1, wherein at least one drug is released from the biodegradable polymer base in a controlled manner.
4. A process for fabricating a bio-scaffold material for treating varicose veins as claimed in claim 1, the process comprising:
forming a biodegradable polymer base from chitosan, alginate, and poly(lactic acid);
encapsulating at least one drug within the biodegradable polymer base, wherein the at least one drug is selected from the group consisting of Amlodipine, Nifedipine, and Prazosin; and
forming the biodegradable polymer base into a patch for topical application to the skin.