Abstract: The present subject matter relates to a multi-layer film (104) coated on a balloon catheter (102) for delivery of a drug to a desired location inside the blood vessel (200), the drug being disposed in the multi-layer film (104). The multi-layer film (104) comprises a first layer (106) that prevents unwanted diffusion of the drug in the blood stream, a second layer (108) that comprise the drug to be delivered and an adhesive layer (110) that adhere to the inner walls of the blood vessel (200) to ensure prolonged drug delivery in the desired location.
DESC:DRUG COATED BALLOON ,CLAIMS:1. A medical balloon device (100) for administering a drug into a blood vessel (200), the medical balloon device (100) comprising:
a balloon catheter (102); and
a multi-layer film (104) adhered on an outer peripheral surface of the balloon catheter (102), the multi-layer film (104) comprising at least one layer carrying a drug carrier for delivering the drug into the blood vessel (200),
wherein the multi-layer film (104) adheres to an inner wall of the blood vessel (200) when the balloon catheter (102) is inflated, and separates from the balloon catheter (102) when the balloon catheter (102) is deflated.
2. The medical balloon device (100) as claimed in claim 1, wherein the multi-layer film (104) comprising at least one layer to keep the blood, flowing within the blood vessel (200), being isolated from the drug.
3. The medical balloon device (100) as claimed in claim 1, wherein the drug carrier releases the drug into the blood vessel (200) at a predetermined rate and for a predefined time period, when the multi-layer film (104) adheres to the inner wall of the blood vessel (200).
4. The medical balloon device (100) as claimed in claim 1, wherein the blood vessel (200) is one of a coronary vessel or a peripheral vessel.
5. The medical balloon device (100) as claimed in claim 1, wherein the multi-layer film (104) comprising an innermost layer, which is made of a semi-permeable material.
6. The medical balloon device (100) as claimed in claim 1, wherein the multi-layer film (104) comprising an outermost layer, which comprises a bio-adhesive agent.
7. The medical balloon device (100) as claimed in claim 1, wherein the multi-layer film (104) comprising one or more intermediate layers between the innermost layer and the outermost layer.
8. The medical balloon device (100) as claimed in claim 7, wherein one of the intermediate layer is coated on the innermost layer.
9. The medical balloon device (100) as claimed in claim 7, wherein the outermost layer is coated on one of the intermediate layer.
10. The medical balloon device (100) as claimed in claim 7, wherein one of the intermediate layer carries the drug carrier and the drug to be administered.
11. The medical balloon device (100) as claimed in claim 1, wherein the drug carrier is a single biodegradable polymer or a blend of multiple biodegradable polymers.
12. The medical balloon device (100) as claimed in claim 1, wherein the multi-layer film (104) comprises perforations (300).
13. The medical balloon device (100) as claimed in claim 1, wherein the perforations (300) extends to the thickness of the outermost layer.
14. A multi-layer film (104) for administering a drug into a blood vessel (200), the multi-layer film (104) comprising:
a first layer (106) coated on the outer peripheral surface of a balloon catheter (102);
a second layer (108) coated on an outer peripheral surface of the first layer (104); and
an adhesive layer (110) coated on an outer peripheral surface of the second layer (108);
wherein the second layer (108) contains the drug and the drug carrier;
wherein, when the balloon catheter (102) inflates, the adhesive layer (110) adheres to the inner wall of the blood vessel (200) and, when the balloon catheter (102) deflates, the multi-layer film (104) detaches from the balloon catheter (102) and adheres to the inner wall of the blood vessel (200); and
wherein the second layer (108) allows the drug carrier to administer the drug to the blood vessel (200) at a predetermined rate and for a predefined time period.
15. The multi-layer film (104) as claimed in claim 14, wherein the first layer (106) keep the blood, flowing within the blood vessel (200), being isolated from the second layer (108).
16. The multi-layer film (104) as claimed in claim 14, wherein the first layer (106) is made of semi permeable material.
17. The multi-layer film (104) as claimed in claim 14, wherein the first layer (106) is a long chain biodegradable polymer which delimits the drug migration through the first layer (106).
18. The multi-layer film (104) as claimed in claim 14, wherein the adhesive layer (110) comprises a bio-adhesive agent.
19. A method for administering a drug into a blood vessel (200), the method comprising;
advancing a multi-layer film (104) coated balloon catheter (102) to a treatment site of the blood vessel (200),
inflating the balloon catheter (102) to adhere the multi-layer film (104) at the treatment site of the blood vessel (200);
deflating the balloon catheter (102) to separate the multi-layer film (104) from the balloon catheter (102);
withdrawing the balloon catheter (102) leaving the multi-layer film (104) carrying a drug carrier and the drug in place at the treatment site of the blood vessel (200); and
allowing the drug carrier for carrying the drug at the treatment site of the blood vessel (200) at a predetermined rate and for a predefined time period.
| # | Name | Date |
|---|---|---|
| 1 | OTHERS [29-03-2016(online)].pdf | 2016-03-29 |
| 2 | Drawing [29-03-2016(online)].pdf | 2016-03-29 |
| 3 | Description(Complete) [29-03-2016(online)].pdf | 2016-03-29 |
| 4 | Form 18 [05-07-2016(online)].pdf_197.pdf | 2016-07-05 |
| 5 | Form 18 [05-07-2016(online)].pdf_196.pdf | 2016-07-05 |
| 6 | Form 18 [05-07-2016(online)].pdf | 2016-07-05 |
| 7 | spr.pdf | 2018-08-11 |
| 8 | SPECIFICATION.pdf | 2018-08-11 |
| 9 | RELEVANT DOCUMENTS.pdf_1114.pdf | 2018-08-11 |
| 10 | RELEVANT DOCUMENTS.pdf | 2018-08-11 |
| 11 | Form-9(Online).pdf | 2018-08-11 |
| 12 | Form-2(Online).pdf | 2018-08-11 |
| 13 | FORM 13.pdf_1113.pdf | 2018-08-11 |
| 14 | Form 13.pdf | 2018-08-11 |
| 15 | FIGURES.pdf | 2018-08-11 |
| 16 | Amended Document.pdf | 2018-08-11 |
| 17 | ABSTRACT1.jpg | 2018-08-11 |
| 18 | 1416-MUM-2015-Form 1-011015.pdf | 2018-08-11 |
| 19 | 1416-MUM-2015-Correspondence-011015.pdf | 2018-08-11 |
| 20 | 1416-MUM-2015-RELEVANT DOCUMENTS [12-08-2019(online)].pdf | 2019-08-12 |
| 21 | 1416-MUM-2015-FORM-26 [12-08-2019(online)].pdf | 2019-08-12 |
| 22 | 1416-MUM-2015-FORM 13 [12-08-2019(online)].pdf | 2019-08-12 |
| 23 | 1416-MUM-2015-ORIGINAL UR 6(1A) FORM 26-130819.pdf | 2019-11-09 |
| 24 | 1416-MUM-2015-Response to office action (Mandatory) [26-12-2019(online)].pdf | 2019-12-26 |
| 25 | 1416-MUM-2015-FER.pdf | 2020-07-07 |
| 26 | 1416-MUM-2015-OTHERS [05-01-2021(online)].pdf | 2021-01-05 |
| 27 | 1416-MUM-2015-FER_SER_REPLY [05-01-2021(online)].pdf | 2021-01-05 |
| 28 | 1416-MUM-2015-DRAWING [05-01-2021(online)].pdf | 2021-01-05 |
| 29 | 1416-MUM-2015-CORRESPONDENCE [05-01-2021(online)].pdf | 2021-01-05 |
| 30 | 1416-MUM-2015-COMPLETE SPECIFICATION [05-01-2021(online)].pdf | 2021-01-05 |
| 31 | 1416-MUM-2015-CLAIMS [05-01-2021(online)].pdf | 2021-01-05 |
| 32 | 1416-MUM-2015-ABSTRACT [05-01-2021(online)].pdf | 2021-01-05 |
| 33 | 1416-MUM-2015-Response to office action [21-06-2022(online)].pdf | 2022-06-21 |
| 34 | 1416-MUM-2015-Response to office action [14-12-2022(online)].pdf | 2022-12-14 |
| 35 | 1416-MUM-2015-US(14)-HearingNotice-(HearingDate-16-02-2023).pdf | 2022-12-21 |
| 36 | 1416-MUM-2015-Correspondence to notify the Controller [13-02-2023(online)].pdf | 2023-02-13 |
| 37 | 1416-MUM-2015-Written submissions and relevant documents [03-03-2023(online)].pdf | 2023-03-03 |
| 38 | 1416-MUM-2015-PatentCertificate28-03-2023.pdf | 2023-03-28 |
| 39 | 1416-MUM-2015-IntimationOfGrant28-03-2023.pdf | 2023-03-28 |
| 40 | 1416-MUM-2015-PROOF OF ALTERATION [31-07-2024(online)].pdf | 2024-07-31 |
| 1 | 1416MUM2015searchstrategyE_06-07-2020.pdf |