Instruments and methods for loading cells into implantable devices

Patent metadata

Field	Value
Publication number	US-11246979-B2
Application number	US-202016912227-A
Country	US
Kind code	B2
Filing date	Jun 25, 2020
Priority date	Nov 20, 2014
Publication date	Feb 15, 2022
Grant date	Feb 15, 2022

Abstract

Embodiments herein describe tools, instruments and methods for aseptic loading, dispensing and/or delivering cells into an implantable device and aseptically and selectively sealing a device inside a sterile package as well as and storing and preparing for shipment the cell-filled device.

First claim

We claim:

1. A method of loading an implantable device with cells, the method comprising:
(a) obtaining a container comprising a flushing volume, a cell volume, and a priming volume;
(b) aspirating first the flushing volume, then the cell volume, and then the priming volume from the container into a dosing tube assembly under negative pressure generated by a pump, wherein a first end portion of the dosing tube assembly is detachably coupled to the pump; and
(c) dispensing first the priming volume, then the cell volume, and then the flushing volume from the dosing tube assembly into the implantable device through an implantable device port under positive pressure generated by the pump, wherein during the act of dispensing, a second end portion of the dosing tube assembly is detachably connected to the device port, such that the implantable device becomes loaded with cells.

2. The method of claim 1 , wherein the first end portion of the dosing tube assembly is detachably connected to a syringe that is detachably connected to the pump.

3. The method of claim 1 , wherein the dosing tube assembly comprises a fluidic reservoir and a dosing tube.

4. The method of claim 3 , wherein the first end portion of the dosing tube assembly comprises the fluidic reservoir.

5. The method of claim 4 , wherein the flushing volume, the cell volume, and the priming volume once aspirated are contained in the fluidic reservoir.

6. The method of claim 3 , wherein the second end portion of the dosing tube assembly comprises the dosing tube.

7. The method of claim 6 , wherein during the act of dispensing, the dosing tube is detachably connected to the device port by a fitting.

8. The method of claim 1 , wherein the cells are pancreatic lineage cells or the cells are pancreatic lineage cell aggregates.

9. The method of claim 8 , wherein the pancreatic lineage cells or pancreatic lineage cell aggregates are pancreatic progenitor cells, PDX-1 positive pancreatic progenitor cells, pancreatic endoderm cells, endocrine precursor cells, endocrine cells, immature beta cells, or immature islet cells.

10. The method of claim 1 , wherein the method is automated, semi-automated, or manual.

11. The method of claim 1 , further comprising (d) sealing the device port after step (c).

12. The method of claim 1 , wherein the implantable device comprises multiple device ports, wherein step (b) comprises aspirating multiple sets of a flushing volume, a cell volume, and a priming volume into the dosing tube assembly from the container and wherein step (c) comprises dispensing each set of a priming volume, a cell volume, and a flushing volume into the implantable device via one of the device ports.

13. The method of claim 1 , wherein the implantable device comprises multiple implantable devices, wherein step (b) comprises aspirating multiple sets of a flushing volume, a cell volume, and a priming volume into the dosing tube assembly from the container and wherein step (c) comprises dispensing each set of a priming volume, a cell volume, and a flushing volume into one of the implantable devices.

14. A method of loading an implantable device with cells, the method comprising:
(a) obtaining a container comprising a flushing volume, a cell volume, and a priming volume;
(b) aspirating first the flushing volume, then the cell volume, and then the priming volume from the container into a dosing tube assembly; and
(c) dispensing first the priming volume, then the cell volume, and then the flushing volume from the dosing tube assembly into the implantable device through an implantable device port, such that the implantable device is loaded with cells.

15. The method of claim 14 , wherein the flushing volume comprises a liquid substantially without cells, the cell volume comprises the liquid with suspended cells, and the priming volume comprises the liquid substantially without the cells.

16. The method of claim 14 , wherein step (b) comprises (i) aspirating the flushing volume from the container, wherein the flushing volume comprises a liquid substantially without cells, (ii) applying positive pressure with a pump to the container to resuspend cells within the container, (iii) aspirating the cell volume from the container, wherein the cell volume comprises the liquid with suspended cells, and (iii) aspirating the priming volume from the container, wherein the priming volume comprises the liquid substantially without the cells.

17. The method of claim 14 , wherein step (b) comprises aspirating first the flushing volume, then the cell volume, and then the priming volume from the container into the dosing tube assembly under negative pressure generated by a pump while a first end portion of the dosing tube assembly is fluidly coupled to the pump and a tip of a second end portion of the dosing tube assembly is inserted into the container, and step (c) comprises dispensing first the priming volume, then the cell volume, and then the flushing volume from the dosing tube assembly into the implantable device through the implantable device port under positive pressure generated by the pump while the first end portion of the dosing tube assembly is fluidly coupled to the pump and the tip of the second end portion of the dosing tube assembly is connected to the implantable device port.

Assignees

• Viacyte Inc

Inventors

• Green Chad
• Martinson Laura
• Olson Erik
• Bellora Val Anthony
• Elliott Leah
• Grant Richard Alexander
• Koenig Donald
• Strollo Giacomo

Classifications

• A61M2209/045

  for filling, e.g. for filling reservoirs · CPC title

• C12N5/0676

  Pancreatic cells · CPC title

• A61F2/022

  Artificial gland structures using bioreactors (hemodialysis A61M1/16; hemofiltration A61M1/34; other extracorporeal blood treatment A61M1/36) · CPC title

• A61M5/14276 Primary

  specially adapted for implantation · CPC title

• A61M5/142

  Pressure infusion, e.g. using pumps · CPC title