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Hemostatic Agent And Method Of Production Thereof

Abstract: A composition (100) and method of preparing the composition for rapid and effective hemostasis is provided. The composition includes a first agent (110) to induce platelet plug formation, a second (120) to induce vasoconstriction and a third agent (130) for activation of coagulation cascade. The composition comprises of 0.01% to 5 % of chitosan; 0.01% to 0.25 % of potassium aluminium sulphate; and 0.01 % to 0.25 % calcium salt. The clotting time of the composition is in the range of 30s to 140s. A method of preparing the hemostatic composition is further disclosed. The composition is configured to control hemorrhage from oozing and pressured bleeding injury any site in human/animal body.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
18 August 2020
Publication Number
08/2022
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
ipo@knspartners.com
Parent Application
Patent Number
Legal Status
Grant Date
2024-02-07
Renewal Date

Applicants

Amrita Vishwa Vidyapeetham
Amrita Centre for Nanosciences & Molecular Medicine AIMS Campus, Amrita Lane, AIMS Ponekkara P.O, Kochi, Kerala, India – 682041

Inventors

1. MONY, Ullas
Amrita Centre for Nanosciences & Molecular Medicine AIMS Campus, Amrita Lane, AIMS Ponekkara P.O, Kochi, Kerala India – 682041
2. VARMA, Praveen Kerala
Department of Cardio Vascular and Thoracic Surgery, AIMS Campus, Amrita Lane, AIMS Ponekkara P.O, Kochi, Kerala, India - 682041
3. SUNDARAM, MuthiahPillai Nivedhitha
Amrita Centre for Nanosciences & Molecular Medicine AIMS Campus, Amrita Lane, AIMS Ponekkara P.O, Kochi, Kerala India – 682041
4. RANGASAMY, Jayakumar
Amrita Centre for Nanosciences & Molecular Medicine AIMS Campus, Amrita Lane, AIMS Ponekkara P.O, Kochi, Kerala India – 682041

Specification

1. A hemostatic hydrogel composition (100) for rapid and synergistic bleeding
control of a patient comprising:
a first agent (110) configured to induce platelet plug formation;
a second agent (120) to induce vasoconstriction; and
a third agent (130) to activate coagulation cascade in the patient.
2. The hemostatic hydrogel composition (100) as claimed in claim 1, wherein:
the first agent (110) is selected from a cationic polymer, a polysaccharide, a protein, an electrostatic agent, and an amine group containing polymer;
the second agent (120) comprises potassium aluminum sulfate, aluminum ammonium sulfate, aluminum sulfate, and aluminum chloride hydrate, a vasoactive catecholamine, a vasoactive peptide, epinephrine, norepinephrine, levonordefrin, isoproterenol, dopamine, methoxamine, phenylephrine; tyramine, amphetamine, methamphetamine, hydroxyamphytamine, metaraminol, ephedrine and mixtures thereof; and the third agent is selected from calcium chloride (CaCl2), calcium oxide (CaO), calcium hydroxide (Ca(OH)2), calcium nitrate (Ca(NO3)2), calcium carbonate (CaCO3), calcium oxalate (C2H2CaO5), magnesium chloride (MgCl2), magnesium oxide (MgO), magnesium hydroxide (Mg(OH)2), magnesium nitrate (Mg(NO3)2), magnesium carbonate (MgCO3), pigeonite and mixtures thereof.
3. The hemostatic hydrogel composition (100) as claimed in claim 1, comprising:
0.01% to 5 % of chitosan (110) as first agent;
0.01% to 0.5 % of potassium aluminium sulphate (120) as second agent; and 0.01 % to 0.5 % a calcium salt (130) as third agent, wherein the clotting time is in the range of 30s to 140s.

4. The composition as claimed in claim 1, comprising protamine sulfate at a dosage of 0.6mg/kg to 1.3mg/kg weight of the patient.
5. The composition as claimed in claim 1, wherein the said hydrogel is formed into a shape selected from sponge, flexible bandage, scaffold, injectable gel, foam, cream and powder form.
6. The composition as claimed in claim 1, wherein the said composition is stable at a temperature range of 25 to 50 °C.
7. The composition as claimed in claim 1, wherein the said composition exhibits one or more characteristics selected from:
a hemolytic potential of 5 percent or less; a RBC aggregation of 0.2 or more; a platelet aggregation of 0.4 or more; and an adhesion strength of 6-10 kPa.
8. The composition as claimed in claim 1, wherein the chitosan has molecular weight in the range of 25 kDa to 1000 kDa, an average degree of deacetylation between 40% to about 99% and degree of acetylation between 1% to about 70%.
9. The composition as claimed in claim 1, comprising:
2 % of chitosan;
0.25 % of potassium aluminium sulphate; and
0.25 % calcium salt.
10. A method (200) of preparing a hemostatic composition (100), comprising:

adding (202) 0.01% to 5% of chitosan powder in acetic acid under continuous stirring to form a chitosan solution;
adding (204) sodium hydroxide to the chitosan solution under continuous stirring to adjust the pH;
centrifuging (206) the said solution to form a chitosan hydrogel;
mixing (208) 0.01% to 0.5% of potassium aluminium sulphate to chitosan hydrogel under vigorous stirring to form a homogeneous mixture;
adding (210) 0.01% to 0.5% calcium chloride to the homogeneous mixture under vigorous stirring to obtain the homogenous mixture of composite hydrogel.
11. The method as claimed in claim 10, wherein the pH of the chitosan solution is adjusted in the range of 6 to 7.

Documents

Orders

Section Controller Decision Date

Application Documents

# Name Date
1 202041035602-IntimationOfGrant07-02-2024.pdf 2024-02-07
1 202041035602-STATEMENT OF UNDERTAKING (FORM 3) [18-08-2020(online)].pdf 2020-08-18
2 202041035602-FORM 1 [18-08-2020(online)].pdf 2020-08-18
2 202041035602-PatentCertificate07-02-2024.pdf 2024-02-07
3 202041035602-Written submissions and relevant documents [01-02-2024(online)].pdf 2024-02-01
3 202041035602-DRAWINGS [18-08-2020(online)].pdf 2020-08-18
4 202041035602-FORM 3 [29-01-2024(online)].pdf 2024-01-29
4 202041035602-DECLARATION OF INVENTORSHIP (FORM 5) [18-08-2020(online)].pdf 2020-08-18
5 202041035602-Correspondence to notify the Controller [11-01-2024(online)].pdf 2024-01-11
5 202041035602-COMPLETE SPECIFICATION [18-08-2020(online)].pdf 2020-08-18
6 202041035602-Proof of Right [23-09-2020(online)].pdf 2020-09-23
6 202041035602-FORM-26 [08-01-2024(online)].pdf 2024-01-08
7 202041035602-US(14)-HearingNotice-(HearingDate-17-01-2024).pdf 2023-12-19
7 202041035602-Form-1_28-09-2020.pdf 2020-09-28
8 202041035602-Response to office action [04-09-2023(online)].pdf 2023-09-04
8 202041035602-RELEVANT DOCUMENTS [09-08-2021(online)].pdf 2021-08-09
9 202041035602-CLAIMS [03-11-2022(online)].pdf 2022-11-03
9 202041035602-FORM-26 [09-08-2021(online)].pdf 2021-08-09
10 202041035602-DRAWING [03-11-2022(online)].pdf 2022-11-03
10 202041035602-FORM 13 [09-08-2021(online)].pdf 2021-08-09
11 202041035602-FER_SER_REPLY [03-11-2022(online)].pdf 2022-11-03
11 202041035602-Request Letter-Correspondence [15-09-2021(online)].pdf 2021-09-15
12 202041035602-Covering Letter [15-09-2021(online)].pdf 2021-09-15
12 202041035602-OTHERS [03-11-2022(online)].pdf 2022-11-03
13 202041035602-CERTIFIED COPIES TRANSMISSION TO IB [15-09-2021(online)].pdf 2021-09-15
13 202041035602-FORM 3 [02-11-2022(online)].pdf 2022-11-02
14 202041035602-EDUCATIONAL INSTITUTION(S) [08-12-2021(online)].pdf 2021-12-08
14 202041035602-FORM-26 [02-11-2022(online)].pdf 2022-11-02
15 202041035602-FORM 18 [09-12-2021(online)].pdf 2021-12-09
15 202041035602-PETITION UNDER RULE 137 [02-11-2022(online)].pdf 2022-11-02
16 202041035602-FER.pdf 2022-05-06
16 202041035602-FORM 3 [07-01-2022(online)].pdf 2022-01-07
17 202041035602-FORM 3 [07-01-2022(online)].pdf 2022-01-07
17 202041035602-FER.pdf 2022-05-06
18 202041035602-FORM 18 [09-12-2021(online)].pdf 2021-12-09
18 202041035602-PETITION UNDER RULE 137 [02-11-2022(online)].pdf 2022-11-02
19 202041035602-EDUCATIONAL INSTITUTION(S) [08-12-2021(online)].pdf 2021-12-08
19 202041035602-FORM-26 [02-11-2022(online)].pdf 2022-11-02
20 202041035602-CERTIFIED COPIES TRANSMISSION TO IB [15-09-2021(online)].pdf 2021-09-15
20 202041035602-FORM 3 [02-11-2022(online)].pdf 2022-11-02
21 202041035602-Covering Letter [15-09-2021(online)].pdf 2021-09-15
21 202041035602-OTHERS [03-11-2022(online)].pdf 2022-11-03
22 202041035602-FER_SER_REPLY [03-11-2022(online)].pdf 2022-11-03
22 202041035602-Request Letter-Correspondence [15-09-2021(online)].pdf 2021-09-15
23 202041035602-DRAWING [03-11-2022(online)].pdf 2022-11-03
23 202041035602-FORM 13 [09-08-2021(online)].pdf 2021-08-09
24 202041035602-FORM-26 [09-08-2021(online)].pdf 2021-08-09
24 202041035602-CLAIMS [03-11-2022(online)].pdf 2022-11-03
25 202041035602-Response to office action [04-09-2023(online)].pdf 2023-09-04
25 202041035602-RELEVANT DOCUMENTS [09-08-2021(online)].pdf 2021-08-09
26 202041035602-US(14)-HearingNotice-(HearingDate-17-01-2024).pdf 2023-12-19
26 202041035602-Form-1_28-09-2020.pdf 2020-09-28
27 202041035602-Proof of Right [23-09-2020(online)].pdf 2020-09-23
27 202041035602-FORM-26 [08-01-2024(online)].pdf 2024-01-08
28 202041035602-Correspondence to notify the Controller [11-01-2024(online)].pdf 2024-01-11
28 202041035602-COMPLETE SPECIFICATION [18-08-2020(online)].pdf 2020-08-18
29 202041035602-FORM 3 [29-01-2024(online)].pdf 2024-01-29
29 202041035602-DECLARATION OF INVENTORSHIP (FORM 5) [18-08-2020(online)].pdf 2020-08-18
30 202041035602-Written submissions and relevant documents [01-02-2024(online)].pdf 2024-02-01
30 202041035602-DRAWINGS [18-08-2020(online)].pdf 2020-08-18
31 202041035602-FORM 1 [18-08-2020(online)].pdf 2020-08-18
31 202041035602-PatentCertificate07-02-2024.pdf 2024-02-07
32 202041035602-IntimationOfGrant07-02-2024.pdf 2024-02-07
32 202041035602-STATEMENT OF UNDERTAKING (FORM 3) [18-08-2020(online)].pdf 2020-08-18

Search Strategy

1 SearchStrategyE_02-05-2022.pdf

ERegister / Renewals

3rd: 06 May 2024

From 18/08/2022 - To 18/08/2023

4th: 06 May 2024

From 18/08/2023 - To 18/08/2024

5th: 06 May 2024

From 18/08/2024 - To 18/08/2025

6th: 03 Jun 2025

From 18/08/2025 - To 18/08/2026