Claims for Patent: 6,623,959

Summary for Patent: 6,623,959

Title:	Devices and methods for cell harvesting
Abstract:	Devices and methods for cell harvesting are disclosed. More particularly this invention relates to devices and methods for enabling the formation of a dispersion of cells from tissue for medical or research use. This invention provides a rapid method for cell isolation thereby reducing the time and costs associated with the production of autologous cells where required, for example, for tissue engineering in the operating theater or in research. Alternately this invention may be used to separate a cell dispersion containing cells of varying sizes or types from a predigested tissue dispersion. Also a kit is disclosed which provides the basic components of the device and instructions on how to accomplish the use of the device.
Inventor(s):	Harris; Ian Ross (Belle Mead, NJ)
Assignee:	Ethicon, Inc. (Somerville, NJ)
Application Number:	09/880,118
Patent Claims:	1. A device for separating cells from tissue comprising a housing defining a cell isolation unit having a first end and a second end, a tissue digestion chamber, a dispersed cell chamber, a waste chamber, and a serum chamber, wherein the first end is adaptable for alternately receiving the tissue digestion chamber and the dispersed cell chamber and the second end is adaptable for alternately receiving the waste chamber and the serum chamber and the second end further containing a filter capable of filtering cells from a dispersion. 2. The device of claim 1, wherein the size of the pores of the filter range from 0.1 to 1000 .mu.m. 3. The device of claim 2, wherein the cell isolation unit is in the form of a tube and the chambers are in the form of tubes having one closed end. 4. The device of claim 2, wherein the chambers are syringes adaptably receivable to the ends of the cell isolation unit. 5. The device of claim 3, wherein the tubes are made from a material selected from the group consisting of polypropylene, polyethylene, polysulfone, Teflon FEP, Teflon PFA, polystyrene, polycarbonate, styrene, acrylonitrile, acrylic, glass, and mixtures thereof. 6. The device of claim 3, wherein the cell isolation unit is of varying inner diameter, wherein the diameter at the first end and second end is up to 10 cm and the smaller inner diameter of the cell isolation unit is in the range of 0.1 mm to 2 mm. 7. The device of claim 1 wherein the first end further comprises a filter capable of substantially preventing any undigested tissue from entering the cell isolation unit. 8. The device of claim 7, wherein the size of the pores of the filter at the first end of the cell isolation unit range from 10 to 1000 .mu.m and the pores of the filter at the second end of the cell isolation unit range from 0.4 to 10 .mu.m. 9. A device comprising a housing defining a cell isolation unit having a first end and a second end, a first dispersed cell chamber, a second dispersed cell chamber, a waste chamber, and a serum chamber, wherein the first end is adaptable for alternately receiving the first dispersed cell chamber and the second dispersed cell chamber and the second end is adaptable for alternately receiving the waste chamber and the serum chamber and the second end further containing a filter capable of filtering cells from a dispersion. 10. A method for isolating cells comprising the steps of: a) providing a cell isolation unit having first and second open ends; b) providing a source of tissue to form cells from tissue digested by a tissue degrading material in a tissue digestion chamber; c) providing a waste chamber; d) providing a source of serum in a serum chamber; e) providing a cell dispersion chamber; f) connecting the tissue digestion chamber to the first end of the cell isolation unit and the waste chamber to the second end of the cell isolation unit; g) applying a force to cause the cells of the tissue digestion chamber to travel through the cell isolation unit thereby capturing the cells at the second end of the unit and allowing the other contents to pass through the cell isolation unit and into the waste chamber; h) disconnecting the tissue digestion chamber and the waste chamber from the cell isolation unit; i) connecting the cell dispersion chamber to the first end of the cell isolation unit and the serum chamber to the second end of the cell isolation unit; and j) applying a force to cause the contents of the serum chamber to pass through the cell isolation unit thereby washing the cells from the cell isolation unit into the dispersed cell chamber. 11. The method of claim 10, wherein the force described in steps g) and j) is centrifugal force. 12. The methods of claim 10, wherein the tissue degrading material are enzymes. 13. The method of claim 12, wherein the enzymes are selected from the group consisting of dispase, neuramidase (Sialidase), pancreatin proteinase K, bromelaine, pronase E, cellulase, dextranase, elastase, plasmin streptokinase, trypsin, chymotrypsin, papain, chymopapain, collagenase, subtilisn, chlostridopeptidase A, ficin, carboxypeptidase A, pectinase, pectinesterase, an oxidoreductase, an oxidase, neutral protease, glycosidase, endopeptidase, pancreatin, metalloprotienase, serine protease, and mixtures thereof. 14. The method of claim 13, wherein the enzyme is trypsin. 15. The method of claim 10, wherein the cell digestion chamber and contents of step b) is incubated at temperature near or at 37 C. 16. The method of claim 10, wherein the serum in step d) is selected from the group consisting of balanced salt solutions, isotonic solutions, cell culture mediums, buffered salines and mixtures thereof. 17. The method of claim 16, wherein the serum is phosphate buffered saline. 18. The method of claim 10, further comprising the step of seeding the contents of the cell dispersion chamber of step j) on a matrix suitable for grafting. 19. The method of claim 10, further comprising the step of inserting the contents of the cell dispersion chamber of step j) as a specific cell therapy to assist or augment the functioning of diseased or injured tissue. 20. A method for isolating cells comprising the steps of: a) providing a cell isolation unit having first and second open ends; b) providing a first dispersion of cells to be separated in a first cell dispersion chamber; c) providing a waste chamber; d) providing a source of serum in a serum chamber; e) providing a second cell dispersion chamber; f) connecting the first cell dispersion chamber to the first end of the cell isolation unit and the waste chamber to the second end of the cell isolation unit; g) applying a force to cause the cells of the first cell dispersion chamber to travel through the cell isolation unit thereby capturing the cells at the second end of the unit and allowing the other contents to pass through the cell isolation unit and into the waste chamber; h) disconnecting the first cell dispersion chamber and the waste chamber from the cell isolation unit; i) connecting the second cell dispersion chamber to the first end of the cell isolation unit and the serum chamber to the second end of the cell isolation unit; and j) applying a force to cause the contents of the serum chamber to pass through the cell isolation unit thereby washing the cells from the cell isolation unit into the second cell dispersion chamber. 21. A kit for separating cells comprising a housing defining a cell isolation unit having a first end and a second end, a first dispersed cell chamber, a second dispersed cell chamber, a waste chamber, and a serum chamber, wherein the first end is adaptable for alternately receiving the first dispersed cell chamber and the second dispersed cell chamber and the second end is adaptable for alternately receiving the waste chamber and the serum chamber and the second end further containing a filter capable of filtering cells from a dispersion with instructions of use comprising the steps of: a) providing a first dispersion of cells to be separated in the first dispersed cell chamber; b) connecting the first dispersed cell chamber to the first end of the cell isolation unit and the waste chamber to the second end of the cell isolation unit; c) applying a force to cause the cells of the first dispersed cell chamber to travel through the cell isolation unit thereby capturing the cells at the second end of the unit and allowing the other contents to pass through the cell isolation unit and the waste chamber; d) disconnecting the first dispersed cell chamber and the waste chamber from the cell isolation unit; e) connecting the second dispersed cell chamber to the first end of the cell isolation unit and the serum chamber containing a serum to the second end of the cell isolation unit; and f) applying a force to cause the contents of the serum chamber to pass through the cell isolation unit thereby washing the cells from the cell isolation unit into the second dispersed cell chamber. 22. A kit for separating cells from tissue comprising a housing defining a cell isolation unit having a first end and a second end, a tissue digestion chamber, a dispersed cell chamber, a waste chamber, and a serum chamber, wherein the first end is adaptable for alternately receiving the tissue digestion chamber and the dispersed cell chamber and the second end is adaptable for alternately receiving the waste chamber and the serum chamber and the second end further containing a filter capable of filtering cells from a dispersion with instructions of use comprising the steps of: a) providing a source of tissue to form cells from tissue digested by a tissue degrading material in the tissue digestion chamber; b) connecting the tissue digestion chamber to the first end of the cell isolation unit and the waste chamber to the second end of the cell isolation unit; c) applying a force to cause the cells of the tissue digestion chamber to travel through the cell isolation unit thereby capturing the cells at the second end of the unit and allowing the other contents to pass through the cell isolation unit and into the waste chamber; d) disconnecting the tissue digestion chamber and the waste chamber from the cell isolation unit; e) connecting the cell dispersion chamber to the first end of the cell isolation unit and the serum chamber containing serum to the second end of the cell isolation unit; and f) applying a force to cause the contents of the serum chamber to pass through the cell isolation unit thereby washing the cells from the cell isolation unit into the dispersed cell chamber.

Details for Patent 6,623,959

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Discure Medical, Llc	CHYMODIACTIN	chymopapain	For Injection	018663	11/10/1982		2039-03-29
Discure Medical, Llc	CHYMODIACTIN	chymopapain	For Injection	018663	08/21/1984		2039-03-29
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2039-03-29