Claims for Patent: 9,907,883

Summary for Patent: 9,907,883

Title:	Method for processing cancellous bone material and related products, methods and uses
Abstract:	Cancellous bone material may be processed in a portable container apparatus to prepare a stromal vascular fraction concentrate. Cancellous bone material may be washed to remove non-bone material, digested and digested material centrifuged, with all operations being performed on cancellous bone material while disposed in the portable container apparatus. Uncultured stromal vascular fraction cells separated from enzyme-digested cancellous bone material, and which contain osteoblasts and osteoclasts, may be removed from the portable container and used without culturing for a variety of medical applications. Medical treatment compositions may be prepared including recovered stromal vascular fraction cells and scaffold material.
Inventor(s):	Llull; Ramon (Palma de Mallorca, ES), Dos Anjos Vilaboa; Severiano (Palma de Mallorca, ES), Cimino; William W. (Louisville, CO)
Assignee:	The GID Group, Inc. (Louisville, CO)
Application Number:	14/440,846
Patent Claims:	1. A method for processing cancellous bone material initially comprising cancellous bone and associated blood, the method comprising; performing processing operations using a portable container apparatus; the portable container apparatus having a filter disposed in an internal containment volume of the portable container apparatus and the internal containment volume includes a retentate volume on one side of the filter and a filtrate volume on another side of the filter; the processing operations comprising: washing, wherein the washing comprises adding aqueous wash liquid to the portable container apparatus to contact cancellous bone material disposed within the retentate volume and removing from the filtrate volume at least a majority of the aqueous wash liquid together with at least some blood washed from the cancellous bone material; after the washing, digesting, wherein the digesting comprises adding to the portable container apparatus a digestion medium comprising collagenase enzyme to contact the digestion medium with at least a washed portion of the cancellous bone material disposed in the retentate volume; and after the digesting, centrifuging the portable container apparatus having disposed within the internal containment volume at least a digested portion of the cancellous bone material, and during the centrifuging forming in the internal containment volume density-separated phases, the density-separated phases including lower-density material phases and a higher-density pellet phase concentrated in stromal vascular fraction cells from the cancellous bone material; and wherein: the apparatus has an access orientation; the internal containment volume includes a pellet well disposed in a bottom portion of the filtrate volume below a bottom elevation of the filter and accessible only from above when the apparatus is in the access orientation; the filtrate volume includes a lower tapered portion below a bottom elevation of the filter and above a top elevation of the pellet well; the lower tapered portion of the filtrate volume is defined by internal wall surfaces of the container that are inclined relative to horizontal at a maximum angle of no larger than 60.degree. when the container is in the access orientation; and at least a portion of the pellet well is defined by a wall surface of the container inclined relative to horizontal at an angle that is larger than the maximum angle of the lower tapered portion when the apparatus is in the access orientation. 2. The method according to claim 1, comprising after the centrifuging, selectively removing material of the pellet phase from the portable container apparatus. 3. The method according to claim 2, wherein the selectively removing comprises: inserting an aspiration tube from outside of to inside of the portable container apparatus to contact the pellet phase inside the portable container apparatus; and aspirating at least a majority of material of the pellet phase through the aspiration tube to outside of the portable container apparatus. 4. The method according to claim 3, wherein: the aspirating comprises aspirating the at least a majority of the material of the pellet phase into a receptacle located outside of the portable container apparatus that is in fluid communication with the aspiration tube; and prior to commencement of the aspirating, the receptacle contains a volume of dispersion medium and during the aspirating the dispersion medium mixes with the at least a majority of the material of the pellet phase in the receptacle; and the volume of the dispersion medium is in a range of from 2 times to 10 times a volume of the at least a majority of the material of the pellet phase that is aspirated into the receptacle during the aspirating. 5. The method according to claim 4, wherein during the aspirating the aspiration tube is in fluid communication with a syringe and the aspirating comprises collecting the at least a majority of the material of the pellet phase in the syringe. 6. The method according to claim 1, wherein: the digesting comprises adding to the portable container apparatus a volume of the digestion medium that provides from 100 to 300 collagen digestion units (CDU) per milliliter of catalytic volume, wherein the catalytic volume is the total of the volume of digestion medium and the volume of the at least a washed portion of the cancellous bone material within the retentate volume; the digestion medium is within a temperature range of from 32.degree. C. to 38.degree. C. when the digestion medium is added to the portable container apparatus; and the digesting comprises after the adding digestion medium, permitting enzymatic digestion within the portable container apparatus for a retention time in a range of from 20 minutes to 60 minutes. 7. The method according to claim 6, wherein: during the retention time the portable container apparatus is disposed in a temperature controlled environment maintained within a temperature range of from 32.degree. C. to 38.degree. C.; and the retention time is in a range of from 25 minutes to 45 minutes. 8. The method according to claim 1, wherein the internal containment volume has an internal processing volume in a range of from 25 cubic centimeters to 400 cubic centimeters. 9. The method according to claim 1, wherein the wall surface of the container defining at least a portion of the pellet well is inclined relative to horizontal at an angle of at least 70.degree. when the apparatus is in the access orientation. 10. The method according to claim 9, wherein: when the apparatus is in the access orientation, the pellet well has at least one portion with a vertical length of at least 0.5 centimeter, a maximum horizontal cross-dimension of no larger than 10 millimeters and a minimum horizontal cross-dimension of no smaller than 1.5 millimeters. 11. The method according to claim 10, wherein the pellet well has a volume in a range of from 0.3 cubic centimeter to 3 cubic centimeters. 12. The method according to claim 11, wherein the pellet well includes a frustoconical portion with an angle of taper relative to horizontal of at least 70.degree. when the container is in the access orientation. 13. The method according to claim 11, comprising removing material of the pellet phase from the portable container apparatus by direct aspiration from the pellet well through an aspiration tube inserted into the pellet into the pellet phase in the pellet well. 14. The method according to claim 11, wherein: the lower tapered portion is a first tapered portion and the pellet well includes a second tapered portion of the internal containment volume that has a greater rate of taper than the first tapered portion; and the internal containment volume includes an available processing volume and the second tapered portion has a volume that is in a range of from 0.2 percent to 2.5 percent of a portion of the available processing volume that is within the retentate volume. 15. The method according to claim 14, wherein the available processing volume is in a range from 25 cubic centimeters to 300 cubic centimeters. 16. The method according to claim 1, wherein when the portable container apparatus is in the access orientation the internal containment volume comprises: a first portion that is cylindrical or is frustoconical tapering toward the bottom of the internal containment volume with an angle of taper relative to horizontal of at least 70.degree.; a second portion disposed below the first portion, the second portion being frustoconical tapering toward the bottom of the internal containment volume with an angle of taper relative to horizontal in a range of from 30.degree. to 60.degree.; a third portion disposed below the second portion in the pellet well, the third portion being cylindrical or frustoconical tapering toward the bottom of the internal containment volume at an angle of taper relative to horizontal of at least 70.degree.. 17. The method according to claim 1, comprising: preparing a medical treatment composition for administration to a human, the preparing a medical treatment composition comprising mixing, outside of the portable container apparatus, a biocompatible scaffold material with at least a portion of the stromal vascular fraction cells from the pellet phase. 18. The method according to claim 1, wherein the filter has a separation size in a range of from 70 microns to 250 microns.

Details for Patent 9,907,883

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2033-01-11