Cell spraying device, method and sprayed cell suspension

Abstract

The invention provides a device and methods suitable for producing a cellular spray of cells. The sprayed cells are of interest for covering and growing on a surface, including a skin wound. In applying the method and/or using the device, cells for grafting onto a patient are dispersed in a solution and sprayed with the device for distribution over the recipient's graft site.

1 . A device for an electronically flow controlled distribution of tissue regenerating cells, including skin cells, in an approximately 0.5-80 ml, preferably 5-40 ml and most preferably 5-20 ml sterile suspension across an area for further growth, via controlled compressed gas and/or pump driven spraying through an electronically pressure and/or flow controlled spray head, providing continuous application over a range of approximately 0.5-10, preferably 1-5 and most preferably 1-2 minutes in a single shot, or several shots, preferably up to 3 shots, while generating suspension drops containing cells ranging between 30-500±200 mm in size, wherin the spray head may be sterilizeable or can be covered with a sterile surgery foil hose, and wherein the following procedures are enabled: (a) subjecting a tissue sample including cells for grafting onto a patient, to at least a physical and/or chemical dissociating means capable of dissociating cells in the tissue sample; (b) taking the cells, which may also have been expanded after the aforementioned step, for spraying into a saline solution, wherein the solution is (i) free of xenogenic serum, (ii) capable of maintaining the the cells alive until applied, (iii) contains electrolytes in a physiologic composition, and (iv) allows direct application to a biomaterial surface or region on a patient undergoing tissue grafting; (c) filtering the cellular suspension produced according to steps (a) and (b) to remove cellular conglomerates of more than 10-500 cells, preferably 50-300 cells and most preferably 50-100 cells; and (d) distributing the cell suspension through the flow controlled spray head onto the receipient surface.  
   
   
       2 . A device according to  claim 1  that is driven via a gas compressor.  
   
   
       3 . A device according to  claim 1  that is driven via a motor.  
   
   
       4 . A device according to  claims 1  to  3 , which contains sensors to measure flow and/or pressure, and/or temperature.  
   
   
       5 . A device according to  claims 1  to  4 , which contains sensors to measure and feedback controls to control flow and/or pressure, and/or temperature.  
   
   
       6 . A device according to  claims 1  to  5 , which transfers the cell suspension from medical-grade disposable sterilizeable syringes, including 0.5-60 ml sterile Luer-lock syringes, preferably 1-50 ml and most preferred 5-20 ml syringes.  
   
   
       7 . A device according to  claims 1  to  6 , which transfers the cell suspension from a medical-grade sterilizeable container, including luer-lock syringes, to the sterilizeable spray head via a disposable filter capable of separating large cellular congregates with a cut off of approximately 5-100 cells, preferably 20-60 cells and most preferred 40 cells from a cellular suspension.  
   
   
       8 . A device according to  claims 1  to  7 , which is battery operated.  
   
   
       9 . A device according to  claims 1  to  8  for distributing a cell suspension, containing a first and second component wherein: (i) the first component includes the power supply, gas/air supply and electronic controls, and (ii) the second component includes a sterilizeable spray head and the container with the cell suspension; and wherein both components are connected through a cable/wire/tube sensor/effector connector, which may be sterilizeable or can be covered with a sterile operation foil hose and has suitable connectors to the components (i) and (ii).  
   
   
       10 . A device according to  claim 1  to  9  for distributing a cell suspension, containing a first and second component wherein both components are wirelessly connected for data exchange, including blue tooth technology to connect sensor/effector controls in the first and second component.  
   
   
       11 . A device according to  claims 1  to  10  which utilizes a solution as an aquaeous solution containing electrolytes in a physiologic composition, including Ringer-Lactate like electrolyte solutions, including Hartman's solution.  
   
   
       12 . A cell suspension produced according to the devices and methods of  claims 1  to  11 .  
   
   
       13 . A cell suspension produced according to at least one of the aforementioned claims prepared from autologous cells, including in vitro expanded autologous cells.  
   
   
       14 . A cell suspension produced according to at least one of the aforementioned claims prepared from stem cells.  
   
   
       15 . A method of utilizing the device according to at least one of the aforementioned claims and producing a cell suspension for treating a patient in need of graft surgery, which is is comprised of the steps: (a) preparing a cell suspension according to the method of  claims 1  to  14 ; and (b) administering the suspension directly to a region on the patient that requires a cell graft in a manner that facilitates spraying of the cell suspension in an even distribution over the graft area.  
   
   
       16 . A method of utilizing the device according to at least one of the aforementioned claims and producing a cell suspension for treating a patient in need of graft surgery with a cell suspension according to one of the aforementioned claims, said devices according to  claims 1  to  11  and administering the suspension to a region on the patient that requires a cell graft in a manner that facilitates spraying of the cell suspension in an even distribution over the graft area.  
   
   
       17 . A method of coating an artificial surface or a biomaterial surface for commercial use with the device according to at least one aforementioned claims, said method is comprised of the steps: (a) preparing a cell suspension according to the method of  claims 1  to  16 ; and (b) administering the suspension directly onto an artificial or a biomaterial that requires a cell coated surface in a manner that facilitates spraying of the cell suspension in an even distribution.