Cell encapsulation loading device

Patent metadata

Field	Value
Publication number	US-2016243344-A1
Application number	US-201615047027-A
Country	US
Kind code	A1
Filing date	Feb 18, 2016
Priority date	Feb 19, 2015
Publication date	Aug 25, 2016
Grant date	—

Abstract

The present invention provides a loading fixture for loading cells, cell clusters, and media to an immune-isolation device. The loading fixture permits the loading of cells into the immune-isolation device without manual manipulation of the immune-isolation device, until the loading device is opened at the point of use, thereby minimizing the risk of contamination of the immune-isolation device.

First claim

What is claimed is:

1 . A system for loading immune-isolation devices comprising:
a base having a base bottom surface and a base wall extending from the base bottom surface to form a cavity; an inlet conduit positioned on the base and extending there through into the cavity of the base; a disk lid removably attachable to the base to seal the cavity; and a blade having an edge slidably disposed within the cavity of the base; wherein the edge of the blade is configured to slide in front of the inlet conduit; and wherein the system is configured to be vented.

2 . The system of claim 1 further comprising a opening in the disk lid.

3 . The system of claim 1 , wherein the blade is disposed on an end of a blade assembly slidably located in the cavity of the base.

4 . The system of claim 3 , wherein the blade assembly is configured to interact ratchedly with the disk lid.

5 . The system of claim 4 , wherein the blade assembly includes a first set of teeth and the disk lid includes a second set of teeth, and wherein the first set of teeth interlock with the second set of teeth.

6 . The system of claim 4 , wherein the blade assembly is semi-circular.

7 . The system of claim 1 , further comprising a snap lid shaped to be complimentary to the disk lid and containing a plurality of snaps which interlock with at least one feature on the base to secure the disk lid to the base.

8 . The system of claim 7 , wherein the at least one feature comprises ramps extending from the base wall, and wherein the plurality of snaps are generally hooked as to engage the at least one feature.

9 . The system of claim 8 , wherein the disk lid further comprises a plurality of snap holes configured to allow at least some of the plurality of snaps to extend there through before engaging the at least one feature.

10 . The system of claim 1 further comprising a junction block having a first opening and a second opening wherein the first opening and second opening define a channel through the junction block, and wherein the first opening is configured to be coupled to the inlet conduit on an outside portion of the base wall.

11 . The system of claim 10 , wherein the channel comprises a plurality of portions, each of the plurality of portions of the channel having different diameters.

12 . The system of claim 11 , wherein a third opening intersects a first one of the plurality of portions of the channel.

13 . The system of claim 12 , wherein the junction block further comprises a first feature proximate to the first opening that interlocks with a second feature on the base wall.

14 . The system of claim 12 , wherein the junction block further comprises a first pin conduit and a second pin conduit configured to receive pins and are located proximate to the second opening of the junction block.

15 . The system of claim 12 further comprising a barb having a shape complimentary to the first one of the plurality of portions, and wherein the barb is configured to be inserted through the channel of the junction block to create a seal in an immune-isolation device or the junction block.

16 . The system of claim 15 further comprising a barb plug having a shape complimentary to a second one of the plurality of portions and having a barb channel proceeding through the barb plug, wherein the barb channel is complimentary to the barb.

17 . The system of claim 16 further comprising a barb pusher comprising a plunger configured to advance the barb through the channel.

18 . The system of claim 1 , wherein the base further comprises a feature on the base bottom surface outside the cavity.

19 . The system of claim 18 , wherein the feature is configured to be gripped by a human hand or interlock with an outside feature during transportation.

20 . The system of claim 1 , wherein the base further comprises a plurality of ribs on the base wall inside the cavity.

21 . The system of claim 20 further comprising a support plate configured to rest on the plurality of ribs.

22 . The system of claim 21 , wherein the support plate further comprises at least one opening.

23 . The system of claim 1 , wherein the base bottom surface is slanted or has a single high point.

24 . The system of claim 1 further comprising an immune-isolation device comprising an inlet tube attached to a pouch, the inlet tube configured to be coupled the inlet conduit positioned on the base within the cavity.

25 . A method of use of a loading device comprising,
providing a loading device comprising,
a base,
a disk lid, having a luer adapter fixedly attached thereto,
a snap lid, wherein the disk lid and snap lid form a cavity in the base,
a blade ring assembly slidably connected to the base,
a junction block fixedly attached to the base and having a luer adapter fixedly attached thereto,
a barb, and a barb pusher slideably connected therein, and
an immune-isolation device comprising an inlet tube and a cell pouch inserted within the cavity wherein the cell pouch rests on the base and the inlet tube is inserted through the junction block,
sterilizing the loading device, filling the cell pouch with cells and the cavity with cell media, sealing the inlet tube with the barb, closing the loading device, transporting the loading device to the point of use, opening the loading device by rotating the disk lid counter-clockwise, thereby cutting the inlet tube, and removing the cell pouch from the loading device at the point of use.

26 . The method of claim 25 , further comprising wetting the cell pouch with hydrophilic liquid.

27 . A method of preparing immune-isolation devices, comprising:
providing a loading system comprising:
a base having a base bottom surface and a base wall extending from the base bottom surface to form a cavity,
an inlet conduit positioned on the base and extending there through into the cavity, and
a disk lid removably attachable to the base to seal the cavity;
coupling an immune-isolation device comprising an inlet tube attached to a pouch, to the inlet conduit positioned on the base within the cavity; sealing the cavity with the disk lid; filling the pouch of the immune-isolation device with cells via the inlet conduit; filling the cavity with cell media; and sealing the inlet tube.

28 . The method of claim 27 further comprising wetting the immune-isolation device prior to filling the pouch.

29 . The method of claim 27 further comprising sterilizing the loading system.

30 . The method of claim 29 , wherein sterilizing comprises at least one of gamma sterilization, e-beam sterilization, and ethylene oxide sterilization.

31 . The method of claim 28 further comprising introducing saline through an opening in the disk lid.

32 . The method of claim 31 , comprising introducing saline without pumps or pressure.

33 . The method of claim 31 further comprising introducing an alcohol through the inlet conduit.

34 . The method of claim 33 further comprising allowing the alcohol and saline to equilibrate.

35 . The method of claim 33 further comprising removing a portion of the alcohol through the inlet conduit.

36 . The method of claim 35 further comprising co

Assignees

• Janssen Biotech Inc

Inventors

• Evans Stephen
• Bell Audrey

Classifications

• A61M31/00 Primary

  Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008}) · CPC title

• A61M2202/09

  Body tissue · CPC title

• A61M2209/045

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

• C12M29/00

  Means for introduction, extraction or recirculation of materials, e.g. pumps (pumps per se F04B) · CPC title

• C12M1/12

  with sterilisation, filtration or dialysis means · CPC title