Title of Invention | A PROCESS OF COLLECTING AND PROCESSING THE BLOOD FROM CORD AND PLACENTA WITH AN UMBILICAL CORD BLOOD BAGS |
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Abstract | An Umbilical Cord blood bag system for a process of collection of blood from Cord and placenta, which comprises a triple bag system with a primary blood collection bag (A) containing coagulant, a first processing satellite bag (B) containing HES solution and a second satellite bag (C) alongwith a first transfer bag(D) containing cryo solution and a second transfer bag (E) containing wash solution all interconnectable suitably. The process comprises of admitting the umbilical blood into bag (A), transferring HES from bag (B) into bag (A), centrifuging bag (A) so as to push the upper leukocytes containing stems cell into bag (B), which bag is further agitated alongwith cryo solution admitted from the bag (D), such that undesired plasma is thrown out to bag (C), followed by wash solution admitted from bag E and then bag B is sealed and chilled. |
Full Text | The fourth objective is the processing of the collected blood in the closed system, by removing RBCs and plasma end getting the isolated stem cells in a small volume of cryo solution. The fifth objective is to preserve the stem cells in the cryo solution at low temperature. The sixth objective is to remove the cryo solution before use of stem cells and resuspend the stem cells in a solution safe for administration. DESCRIPTION OF INVENTION The umbilical blood bag system as per the invention includes the following :- (a) a bag for collection of umbilical cord and placenta from the delivery room (X) (b) a mounting stand for the placenta and cord (Y). (c) A triple bag system which contains i) a primary blood collection bag (A) ii) a first processing Satellite Bag (B) iii) a second Satellite Bag (C) (d) First Transfer Pack (D) (e) Second Transfer Pack (E) alongwith connecting tubes x and y. • wherein bag (X) means a sterile plastic bag with adhesive top for closing for the collection of placenta after it has been delivered and the umbilical cord clamped and cut. ■ wherein Stand (Y) means a mounting device made of perspex for mounting the placenta and cord. (Cord hanging down) ft ■ wherein the primary umbilical cord blood collection bag (A) (200ml capacity) made of trimellitate plasticised PVC bag, includes one inlet port with tube accommodating two donor needles; two additional inlet/outlet ports and a tube (x) communicating with the first satellite bag (B). ■ wherein further the primary Collection bag (A) contains CPD as the coagulant solution. ■ wherein the first satellite Bag (B) (100ml capacity) made of polyolefene or polyvinyl acetate has two inlet/outlet port to accommodate transfer pack D and transfer pack E, and a tube (x) communicating with Bag (A) and tube (y) communicating with second satellite Bag (C). ■ wherein further the first satellite Bag (B) contains (Hydroxy ethyl starch) HES solution, ■ wherein the second satellite Bag (C) has two inlet/outlet ports and tube (y) communicating with Bag (B). ■ wherein transfer pack (D) (50ml, Trimellitate plasticized PVC bag) has one output tube with needle (spike) to transfer solution to Bag (B), alongwith one inlet/outlet port. ■ Wherein further transfer pack (D) contains 50ml Phosphate buffered containing 5% dextrose + 5ml of cryo solution (55% Dimethyl Sulfoxide and 5% dextran 40). ■ Wherein transfer pack (E), |200ml, Trimellitate plasticized PVC bag] has one output tube with needle (spike) to transfer solution to Bag B, alongwiih two inlet/outlet ports. ■ Wherein further pack (E) further contains Wash solution. (Phosphate buffered containing 0.2% glucose) ■ Wherein both tubes x and y have tube closing devices (clamps). The above paras have described the various bags, packs, ports and tubes used as apparatus/means to achieve the object of the invention. We now give below the process and sequence involved for collecting umbilical blood, separation of stem cells and their further storage until use in recipients. The process steps in sequence using the above system as per the invention are :- 1. Collection of Placenta Collection of placenta after it has been delivered and the umbilical cord clamped and cut in the sterile plastic bag (X) and its transfer to a laminar flow in a sterile room. 2. Mounting of Placenta & Cord The placenta with umbilical cord afler wiping with sterile cotton soaked in isopropanol is mounted on the stand (Y), with the cord hanging down. The first donor needle (1) from Collection Bag (A) is penetrated into cord vein such that the blood from umbilical cord falls via gravity into Bag (A) and further extraction of blood is done by repeating the above mentioned collection process with needle (2) of Collection bag (A) but only after removing first donor needle WE CLAIM : 1. An Umbilical cord blood bag system for a process of collecting and processing the umbilical cord blood to obtain stem cells and storing the stem cells and for using the stored stem cells, the said process comprising of following sequence and steps :- 1(a) Collecting umbilical cord blood from umbilical cord fitted onto stand (Y) into the collection bag (A) and mixing the collected umbilical cord blood with anti-coagulant solution present in the collection Bag (A). 1(b) Admitting of H£S solution from Bag (B) into Bag (A) via the inter connecting tube, within the closed sterile collection bag system and thereby draining the Bag B empty. 1(c) Centrifuge at approximately 50 times gravitational force the contents in Bag (A) so as to separate the blood into (_) upper leukocyte rich plasma containing stem cells and; (_) lower sedimented unwanted red cells. 1(d) Transferring the upper leukocyte rich plasma containing stem cells from Bag (A) to Bag (B). 1(e) Centrifuge the contents in Bag (B) at a higher speed of 500 times gravitational force so as to separate the plasma into 2 layers. (_) Lower layer containing stem cells as pellet. (_) Upper Layer mainly of unwanted plasma. 1(f) Transfer away the unwanted upper layer mainly of unwanted plasma from Bag (B) to Bag (C) for disposal thus leaving behind stem cells as pellet back in Bag (B), 1(g) Transferring the cryo solution from transfer pack (D) into bag (B) and mixing contents in Bag (B) to obtain stem cell suspension. 1(h) Sealing of Bag B and C from bag A at collection temperature of 15 - 20" C. l(i) Cooling the sealed bag (B) with bag C at the rate of 1- 2° C per minute until -40oC for storing purposes for short term storage or to liquid nitrogen temperature (- 196oC) for long term storage. l(j) Using the stored stem cells suspension stored in Bag (B) when the need arises, following the sequence steps just prior to as mentioned herein below : A. Thaw the stored Bag (B) containing stored stem cell suspension, centrifuge and remove unwanted supernatant to bag C. B. Adding wash solution contained in transfer pack (£) to Bag (B) and mixing. C. Centrifuge the contents of stored bag (B) for separation of suspended stem cells and transfer the unwanted supernatant to bag C. Suspend stem cell pellets in wash solution (sterile buffered saline containing 0.2 % solution) from transfer pack E, for use on the recipient. D. Resuspend the stem cells pellets in required volume of wash solution from transfer bag E. The suspend stem cells are now be used in the recipient. 2. An umbilical and blood bag system claimed in claim 1, comprises of:- 2(a) (-) a stand (Y) for mounting placenta and cord. 2(b) (-) a closed sterile Triple Bag System which includes Collection Bag (A); first satellite processing Bag (B) and second satellite bag (C) alongwith two Transfer packs (D) and (E) which are separate and connectable to Bag (B) under sterile condition such that the collection Bag (A) is containing anti-coagulant, Bag (B) is containing HES, transfer pack (D) is containing cryo solution and transfer pack (E) is containing wash solution. Each bag separate but communicable with the adjacent bag via connector tubes x and y and also including further transfer pack (D) containing cryo solution and transfer pack (E) containing wash solution which are connectable and detachable from Bag (B). 2(c) Means for admitting umbilical cord blood into collection bag (A) for mixing the admitted umbilical blood with the said anti-coagulant which means includes collection input port with double donor needle system in the collection bag (A). 2(d) Means for transferring HES from Bag (B) into Bag (A) which includes a tube (x). 2(e) Means for separation by centrifugation of contents in Bag (A). 2(i) Means for transferring upper (desired) leukocytes containing stem cells layer contents from Bag (A) into Bag (B) which is the said tube (X). 2(g) Means for further separation by centrifugation of contents in Bag (B) which means includes an agitator. 2(h) Means for transferring upper (undesired) plasma layer contents from Bag (B) into Bag (C) which means includes a tube (y). 2(i) Means for admitting cryo solution from transfer pack (D) into said Bag (B) which includes an input port and a clamp. 2(]) Means for sealing Bag (B) with bag C which means includes a clamp. 2(k) Means for cooling Bag (B) which means includes refrigeration. 2(1) Means for admitting wash solution for transfer pack (E) into said Bag (B) which means includes an input port and a clamp. 3. An Umbilical cord blood bag system and process for collecting and processing the umbilical cord blood and storing the stem cells and for using the stored stem cells as claimed in claim 1(a), includes the following three steps :- (i) Mounting the placenta and cord on stand (Y) suitably; (ii) Collecting blood through first needle of collecting bag (A) by flow by gravity until blood ceases to flow into collection bag (A); (iii) Collecting blood through the second needle of collecting bag (A) after sealing the first needle until the cord turns white to ensure maximum extraction of blood from the cord. 4. An Umbilical cord blood bag system and process for collecting and processing the umbilical cord blood and storing the stem cells and for using the stored stem cells as claimed in claim 1(b), wherein the final concentration of HES in the blood in Bag (A) is 2 to 3%. 5. An Umbilical cord blood bag system and process for collecting and processing the umbilical cord blood and storing it as stem cells and for using the stored stem colls as claimed in claim 1(c), wherein the separation by first centrifugation is done at 50 times the gravitational force for a period of 6 minutes. 6. An Umbilical cord blood bag system and process for collecting and processing the umbilical cord blood and storing it as stem cells and for using the stored stem cells as claimed in claim 1(e), wherein separation by second centrifugation is done at 500 times the gravitational force for a period of 15 minutes. 7. An Umbilical cord blood bag system and process for collecting and processing the umbilical cord blood and storing it as stem cells and for using the stored stem cells as claimed in claim 1(g), wherein cryo solution means phosphate buffered saline containing 5ml dextrose (5%) solution + 5 ml of cryo solution (55% DMSO + 5% dextran 40) contained in transfer pack (D). 8. An Umbilical cord blood bag system and process for collecting and processing the umbilical cord blood and storing it as stem cells and for using the stored stem cells as claimed in claim l{j) (ii), wherein wash solution means phosphate buffered physiological saline containing 0.2% glucose. 9. An Umbilical cord blood bag system and process for collecting and processing the umbilical cord blood and storing it as stem cells and for using the stored stem cells as claimed in claim 1 85 2(b), wherein collection bag (A) includes one collection blood inlet port accommodated with two donor needles; 2 additional inlet/outlet ports and a tube communication (x) with satellite bag (B). 10. An Umbilical cord blood bag system and process for collecting and processing the umbilical cord blood and storing it as stem cells and for using the stored stem cells as claimed in claim 1 & 2(b), wherein second processing bag (B) includes two inlet/outlet porta to accommodate transfer pack D and transfer pack E, a tube commuricating (x) with collection bag (A) and tube communicating (y) with second satellite bag (C). 11. An Umbilical cord blood bag system and process for collecting and processing the umbilical cord blood and storing it as stem cells and for using the stored stem cells as claimed in claim 1 and 2(b), wherein satellite bag (C) has two inlet/outlet ports and single communication tube (y) with first satellite bag (B). 12. An Umbilical cord blood bag system and process for collecting and processing the umbilical cord blood and storing it as stem cells and for using the stored stem cells as claimed in claim 1 and 2(b), wherein transfer pack D has one controlled output tube with needle adaptable to and detachable from Bag (B) alongwith two inlet/outlet ports. 13. An Umbilical cord blood bag system and process for collecting and processing the umbilical cord blood and storing it as stem cells and for using the stored stem cells as claimed in claim 1 and 2(b), wherein transfer pack E has one controlled output tube with needle adaptable to and detachable from Bag (B) alongwith two inlet/outlet ports. 14. An Umbilical cord blood bag system and process for collecting and processing the umbilical cord blood and storing it as stem cells and for using the stored stem cells as claimed in claim 2, wherein Bag (A) is detachable. 15. An Umbilical cord blood bag system and process for collecting and processing the umbilical cord blood and storing it as stem cells and for using the stored stem cells as claimed in claim 2, wherein Bag (B) is detachable. 16. An Umbilical cord blood bag system and process for collecting and processing the umbilical cord blood and storing it as stem cells and for using the stored stem cells as claimed in claim 2, wherein Bag (C) is detachable. 17. An Umbilical oord blood bag system and process for collecting and processing the umbilical cord blood and storing it as stem cells and for using the stored stem cells as claimed in claim 2, wherein Transfer pack (D) is attachable and detachable. 18. An Umbilical cord blood bag system and process for collecting and processing the umbilical cord blood and storing it as stem cells and for using the stored stem cells as claimed in claim 2, wherein transfer pack (E) is attachable and detachable. 19. An Umbilical cord blood bag system and process for collecting and processing the umbilical cord blood and storing it as stem cells and for using the stored stem cells as illustrated in accompanying drawings. 20. An Umbilical cord blood bag system and process for collecting and processing the umbilical cord blood and storing it as stem cells and for using the stored stem cells as described in Complete Specifications. |
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0041-mas-2002 abstract-duplicate.pdf
0041-mas-2002 claims duplicate.pdf
0041-mas-2002 claims-duplicate.pdf
0041-mas-2002 correspondence-others.pdf
0041-mas-2002 correspondence-po.pdf
0041-mas-2002 description (complete)-duplicate.pdf
0041-mas-2002 description (provisional).pdf
Patent Number | 217060 | |||||||||
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Indian Patent Application Number | 41/MAS/2002 | |||||||||
PG Journal Number | 21/2008 | |||||||||
Publication Date | 23-May-2008 | |||||||||
Grant Date | 24-Mar-2008 | |||||||||
Date of Filing | 18-Jan-2002 | |||||||||
Name of Patentee | TERUMO PENPOL LIMITED | |||||||||
Applicant Address | IX/1323, SASTHAMANGALAM, TRIVANDRUM - 695 010, | |||||||||
Inventors:
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PCT International Classification Number | A61B 5/15 | |||||||||
PCT International Application Number | N/A | |||||||||
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