INSTRUMENTS AND METHODS FOR LOADING CELLS INTO IMPLANTABLE DEVICES

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.

Description

Claims

1. A cell loading system for transferring cells from a cell source to an implantable device, the loading system comprising: a support for supporting the implantable device;a dosing tube assembly comprising a dosing tube and a fluid reservoir tube fluidly connected to the dosing tube, wherein the dosing tube has an outlet end that is positionable in the cell source to draw cells from the cell source into the dosing tube assembly and then removed from the cell source and positioned in the implantable device to inject cells contained in the dosing tube assembly into the implantable device; anda syringe pump comprising a piston, a cylinder, and a motor configured to control displacement of the piston relative to the cylinder, wherein the syringe pump is fluidly connected to the fluid reservoir tube, wherein the syringe pump is operable to draw cells from the cell source into the dosing tube assembly under negative pressure when the outlet end of the dosing tube is in the cell source, and the syringe pump is further operable to pump cells contained in the dosing tube assembly into the implantable device under positive pressure when the outlet end of the dosing tube is in the implantable device.

2. The cell loading system of claim 1, wherein the fluid reservoir tube has a first end fluidly connected to the dosing tube, a second end fluidly connected to the syringe pump, and a portion between the first and second ends that is wound into a coil.

3. The cell loading system of claim 2, further comprising a mounting surface for supporting the coil in a horizontal position.

4. The cell loading system of claim 1, wherein the dosing tube assembly further comprises a fitting connecting the dosing tube to the fluid reservoir tube.

5. The cell loading system of claim 4, further comprising a mount for holding the fitting and positioning the dosing tube relative to the cell source and the implantable device.

6. The cell loading system of claim 1, wherein the height of the outlet end of the dosing tube relative to an interior of the cell source is adjustable when the outlet end of the dosing tube extends into the cell source.

7. The cell loading system of claim 1, further comprising the implantable device, wherein the implantable device is a cell encapsulation device.

8. The cell loading system of claim 1, further comprising the cell source, wherein cell source is a cell container, a cell reservoir, or a cell vial and cells stored therein.

9. The cell loading system of claim 8, wherein the cells are pancreatic-type cells.

10. The cell loading system of claim 8, wherein the cells are pancreatic progenitor cells, endocrine precursor cells, immature beta cells, or immature islet cells.

11. A cell loading system comprising: an implantable device;a cell source;a dosing tube assembly comprising a dosing tube and a fluid reservoir tube fluidly connected to the dosing tube, wherein the dosing tube has an outlet end that can be inserted into and removed from the cell source and inserted into and removed from the implantable device; anda syringe pump comprising a piston, a cylinder, and a motor configured to control displacement of the piston relative to the cylinder, wherein the syringe pump is fluidly connected to the fluid reservoir tube, wherein the syringe pump is operable to draw cells from the cell source into the dosing tube assembly under negative pressure when the outlet end of the dosing tube is inserted into the cell source, and the syringe pump is further operable to pump cells contained in the dosing tube assembly into the implantable device under positive pressure when the outlet end of the dosing tube is inserted into the implantable device.

12. The cell loading system of claim 11, further comprising means for adjusting the height of the dosing tube relative to the cell source and the implantable device.

13. The cell loading system claim 11, wherein the implantable device comprises a device port, and wherein the dosing tube assembly comprises a fitting positioned between the device port and the dosing tube when the dosing tube is inserted into the device port.

14. A method for loading an implantable device with cells, the method comprising: (a) inserting a dosing tube of a dosing tube assembly into a container that contains cells suspended in a liquid;(b) aspirating cells from the container into the dosing tube assembly under negative pressure generated by a pump;(c) removing the dosing tube from the container;(d) inserting the dosing tube into an implantable device; and(e) dispensing the cells from the dosing tube assembly into the implantable device under positive pressure generated by the pump.

15. The method of claim 14, wherein step (b) comprises aspirating first a flushing volume from the container, then a cell volume that includes the cells from the container, and then a priming volume from the container.

16. The method of claim 15, wherein step (e) comprises dispensing first the priming volume, then the cell volume, and then the flushing volume from the dosing tube assembly into the implantable device.

17. The method of claim 15, wherein step (b) comprises (i) aspirating the flushing volume from the container, wherein the flushing volume comprises the liquid without cells, (ii) applying positive pressure with the pump 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 (iv) aspirating the priming volume from the container, wherein the priming volume comprises liquid without the cells.