Claims for Patent: 10,376,658

Summary for Patent: 10,376,658

Title:	Device for cell spraying
Abstract:	The invention provides a description of a method and a device suitable for producing a cell suspension spray with living cells, and the produced cell preparation, suitable for grafting to a patient. In contrast to other methods, the spraying is performed through a disposable needle which is inserted into a disposable air tube; which provides a cell distribution avoiding spray nozzles. Small suspension droplets are provided instead of cell nebulization. By using medical grade sterile Luer-lock disposables from medical routine praxis, biocompatibility and easy application is addressed. In applying the method and/or in using the device, cells suitable for grafting to a patient are dispersed in a solution and sprayed with the device for distribution over the recipient graft site.
Inventor(s):	Bornemann; Reinhard (Bielefeld, DE)
Assignee:	RenovaCare Sciences Corp. (New York, NY)
Application Number:	15/360,230
Patent Claims:	1. A cell spray gun comprising: a tube having a first end, a second end, and a discharge portion proximate to the second end; a gas source in connection with the first end of the tube and configured to deliver a gas stream from the first end of the tube and out through the second end of the tube; a support portion configured to receive and secure a container containing a cell suspension; one hollow needle having a first end and a second end opposite the first end, the first end of the needle removably attached to the container when the container is secured in the support portion, the needle configured for delivery of the cell suspension from the container into the first end of the needle and out through the second end of the needle; and an actuator configured to push the cell suspension out of the container and out through the second end of the needle, wherein the second end of the needle is disposed inside the discharge portion of the tube such that the needle and the discharge portion are arranged coaxially and the cell suspension is injected into the gas stream and sprayed from the second end of the tube as suspension droplets. 2. The cell spray gun of claim 1 wherein the gas source provides sterile filtered air. 3. The cell spray gun of claim 1 wherein the container is a syringe. 4. The cell spray gun of claim 3 wherein the syringe includes a plunger, and the actuator advances the plunger within the syringe. 5. The cell spray gun of claim 1 wherein the actuator includes at least one of a pneumatic actuator, a gas actuator, a hydraulic liquid membrane, or a mechanical/electromechanical actuator. 6. The cell spray gun of claim 1 further comprising: a filter between the support portion and the needle, the filter configured to separate large cellular congregates from the cell suspension prior to transferring the cell suspension from the container to the needle. 7. The cell spray gun of claim 1 wherein the cell suspension in the container comprises progenitor skin cells in a serum-free physiological solution, the cell spray gun is configured to spray the cell suspension onto a wounded area of skin on a human subject, and the cells are obtained from the subject's normal skin tissue that has been treated with enzymes thereby causing the cells to release from the dermal-epithelial cell junction. 8. The cell spray gun of claim 7 wherein the cells are uncultured cell types in a ratio comparable to that found in normal skin and comprise basal keratinocytes, Langerhans cells, fibroblasts and melanocytes. 9. The cell spray gun of claim 8 wherein the skin cells have not been subjected to ex vivo expansion. 10. The cell spray gun of claim 7 wherein the enzymes include at least one of trypsin, dispase, collagenase, trypsin-EDTA, thermolysin, pronase, hyaluronidase, elastase, papain and pancreatin. 11. A cell spray gun comprising: a tube having a first portion and a second portion; a gas supply for delivering a gas stream through the tube, the first portion of the tube is connected to the gas supply, wherein the gas stream exits the tube at the second portion; a container configured for removably containing a cell suspension; a hollow needle configured to deliver the cell suspension from the container, the hollow needle having a first portion connected to the container and a second portion for delivering the cell suspension out of the needle, the hollow needle intersecting a wall of the tube between the first and second portions of the tube, the hollow needle and the second portion of the tube arranged coaxially; an actuator coupled to the container and configured to push the cell suspension out of the container; and a spray head configured to spray the cell suspension onto a surface, the spray head including the second portion of the hollow needle disposed within the second portion of the tube such that the spray head generates suspension drops in the gas stream. 12. The cell spray gun of claim 11 wherein the gas supply includes filtered air. 13. The cell spray gun of claim 11 wherein the needle intersects with the tube at a curved portion of the tube located between the first portion and the second portion. 14. The cell spray gun of claim 11 further comprising: a handle; and a user-operable control coupled to the handle, wherein the actuator is operable in response to the control. 15. The cell spray gun of claim 14 wherein the actuator includes a motor. 16. The cell spray gun of claim 11 wherein the cell suspension in the container comprises progenitor skin cells in a serum-free physiological solution, the spray head is configured to spray the cell suspension onto a wounded area of skin on a human subject, and the cells are obtained from the subject's normal skin tissue that has been treated with enzymes thereby causing the cells to release from the dermal-epithelial cell junction. 17. The cell spray gun of claim 16 wherein the cells are uncultured cell types in a ratio comparable to that found in normal skin and comprise basal keratinocytes, Langerhans cells, fibroblasts and melanocytes. 18. The cell spray gun of claim 16 wherein the enzymes include at least one of trypsin, dispase, collagenase, trypsin-EDTA, thermolysin, pronase, hyaluronidase, elastase, papain and pancreatin. 19. A cell spray gun comprising: a tube having a first end, a second end, and a discharge portion proximate to the second end; a gas source in connection with the first end of the tube and configured to deliver a gas stream from the first end of the tube and out through the second end of the tube; a support portion configured to receive and secure a container containing a cell suspension; one hollow needle having a first end and a second end opposite the first end, the needle configured for connection to the container when the container is secured in the support portion and configured for delivery of the cell suspension from the container into the first end of the needle and out through the second end of the needle; and an actuator configured to push the cell suspension out of the container and out through the second end of the needle, wherein the second end of the needle is disposed inside the discharge portion of the tube such that the needle and the discharge portion are arranged coaxially and the cell suspension is infected into the gas stream and sprayed from the second end of the tube as suspension droplets, wherein a wall of the tube is penetrated by the needle. 20. A cell spray gun configured to receive a container containing a cell suspension, the cell spray gun comprising: a tube having a first end, a second end, and a discharge portion proximate to the second end; a gas source in connection with the first end of the tube and configured to deliver a gas stream from the first end of the tube and out through the second end of the tube; a hollow needle having a first end and a second end opposite the first end, the needle configured for connection to the container at the first end of the needle when the container is received in the cell spray gun, the needle configured for delivery of the cell suspension from the container into the first end of the needle and out through the second end of the needle, and the needle penetrates a wall of the tube such that the second end of the needle is disposed inside the discharge portion of the tube, and the needle and the discharge portion are arranged coaxially; and a spray head configured to spray the cell suspension onto a surface, the spray head including the second end of the needle disposed inside the discharge portion of the tube, and the spray head generates suspension drops in the gas stream.

Details for Patent 10,376,658

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	05/05/2004		2032-08-13
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	12/02/2004		2032-08-13
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10/26/2004		2032-08-13
Akorn, Inc.	HYDASE	hyaluronidase	Injection	021716	10/25/2005		2032-08-13
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2032-08-13