Modular single-use kits and methods for preparation of biological material

Abstract

Disclosed herein are standardized and optimized, modular single-use kits and methods for sterile or non-sterile preparation of biological material, such as cells or tissue, for immediate use, further preparation, or storage. These single-use kits comprise at least one single-use component necessary for the preparation of biological material in accordance with a particular method as set forth in the instructions for use included with each particular type of single-use kit that set forth a unique method for using that particular type of single-use kit. The single-use kit of the invention comprises at least one modular, single-use packaging frame wherein at least one modular, single-use tray with an identifying is disposed, wherein at least one single-use component is organized. The identifying label on each modular single-use tray corresponds to (correlates with) a sequence of steps set forth in the instructions included with each single-use kit. The single-use kits of the invention facilitate and improve a healthcare practitioner's ability to prepare biological material for research, diagnostic and therapeutic purposes in a convenient, consistent, repeatable, safe and effective manner.

What is claimed is: 
     
         1 . A standardized and optimized, modular, single-use kit for sterile or non-sterile preparation of biological material, the single-use kit comprising:
 at least one modular single-use packaging frame;   at least one modular single-use tray disposed within the packaging frame comprised in the single-use kit, wherein at least one single-use tray disposed within the packaging frame comprised in the single-use kit has an identifying label;   at least one single-use component organized within any single-use tray disposed within the packaging frame comprised in the single-use kit; and   printed instructions for use comprising a sequence of steps directing use of the single-use kit for the sterile or non-sterile preparation of biological material, wherein one or more of the steps of the instructions corresponds to (correlates with) the identifying label on one or more of any single-use tray disposed within the packaging frame comprised in the single-use kit.   
     
     
         2 . The kit of  claim 1 , wherein a plurality of the labeled trays are disposed within the packaging frame comprised in the kit, with each labeled tray having at least one component organized therein. 
     
     
         3 . The kit of  claim 2 , wherein the plurality of labeled trays are labeled sequentially, with numbers or letters in ascending or descending order, and one or more steps of the instructions correspond to (correlate with) the sequentially labeled trays. 
     
     
         4 . The kit of  claim 3 , wherein the components and the sequence of steps set forth in the instructions are for the preparation of biological material. 
     
     
         5 . The kit of  claim 3 , wherein the components are sterile and the sequence of steps set forth in the instructions are for the sterile preparation of biological material (e.g., for use as a sterile research kit, diagnostic kit, or other kit for preparing biological material). 
     
     
         6 . The kit of  claim 3 , wherein the components are sterile and the sequence of steps set forth in the instructions are for the sterile harvesting and sterile preparation of biological material (e.g., for use as a diagnostic kit or other single-use kit disclosed herein wherein the biological material is not immediately reintroduced into the subject). 
     
     
         7 . The kit of  claim 3 , wherein the components are sterile and the sequence of steps set forth in the instructions are for the sterile harvesting, sterile preparation, and sterile utilization of biological material for implantation or other such therapeutic use(s). 
     
     
         8 . The kit of  claim 1 , wherein one or more of the sequence of steps set forth in the instructions are for the concentration and use of cells and/or tissue. 
     
     
         9 . The kit of  claim 1 , wherein one or more of the sequence of steps set forth in the instructions are for the identification, isolation and use of nucleated cells. 
     
     
         10 . The kit of  claim 1 , wherein one or more of the sequence of steps set forth in the instructions are for the identification, isolation and use of stem cells. 
     
     
         11 . The kit of  claim 1 , wherein the packaging frame comprises a top and bottom with complementary features that facilitate stable stacking of the packaging frame with vertically adjacent packaging frames. 
     
     
         12 . The kit of  claim 1 , wherein the packaging frame comprises a plurality of labeled trays, wherein the trays can be slid partially out of, or be completely removed from, the packaging frame. 
     
     
         13 . The kit of  claim 1 , further comprising a reservoir for the disposal of liquid biological waste. 
     
     
         14 . The kit of  claim 13 , wherein the reservoir is a disposable bag, and wherein the single-use tray includes a port to accommodate a tube for connection to the bag. 
     
     
         15 . The kit of  claim 13 , wherein the packaging frame comprises at least one wall, and wherein the at least one wall has the reservoir therein, with at least one port in the reservoir aligned with at least one port in the at least one wall, for the disposal of liquid biological waste. 
     
     
         16 . A method for sterile or non-sterile preparation of biological material, comprising providing a standardized and optimized, modular, single-use kit of  claim 1 , and carrying out the sequence of steps in the printed instructions directing use of the single-use kit. 
     
     
         17 . The method of  claim 16 , wherein the sequence of steps set forth in the instructions are for the sterile harvesting and sterile preparation of biological material which is to be further prepared, and wherein the sequence of steps comprises:
 (1) setting up a sterile work area;   (2) setting up equipment;   (3) preparing the patient;   (4) harvesting the biological material;   (5) centrifuging biological material (with or without a rinse solution);   (6) collecting certain portions of the centrifuged biological material to be set aside;   (7) collecting certain portions of the biological material for further preparation;   (8) further preparing certain portions of the biological material (e.g., by using incubation and/or a reagent treatment);   (9) combining certain portions of the further-prepared biological material with certain portions of the biological material that was set aside;   (10) preparing the combined biological material for further preparation; and   (11) temporarily storing the combined biological material to be further prepared.   
     
     
         18 . The method of  claim 16 , wherein one or more of the sequence of steps set forth in the instructions are for the concentration and use of cells and/or tissue. 
     
     
         19 . The method of  claim 16 , wherein one or more of the sequence of steps set forth in the instructions are for the identification, isolation and use of nucleated cells. 
     
     
         20 . The method of  claim 16 , wherein the kit comprises:
 at least one modular single-use packaging frame;   at least one modular single-use tray disposed within the packaging frame comprised in the single-use kit, wherein at least one single-use tray disposed within the packaging frame comprised in the single-use kit has an identifying label;   at least one single-use component organized within any single-use tray disposed within the packaging frame comprised in the single-use kit; and   printed instructions for use comprising a sequence of steps directing use of the single-use kit for the sterile or non-sterile preparation of biological material, wherein one or more of the steps of the instructions corresponds to (correlates with) the identifying label on one or more of any single-use tray disposed within the packaging frame comprised in the single-use kit,   wherein a plurality of the labeled trays are disposed within the packaging frame comprised in the kit, with each labeled tray having at least one component organized therein,   wherein the plurality of labeled trays are labeled sequentially, with numbers or letters in ascending or descending order, and one or more steps of the instructions correspond to (correlate with) the sequentially labeled trays, wherein the kit has a single packaging frame (referred to herein as a preparation sub-kit) that is disposed with at least one tray organized with syringes that each comprise a syringe barrel and plunger, wherein the syringe barrel has a syringe-tip with a quick-release connector (e.g., Luer Taper, Luer-Lock or Luer-Slip), wherein the plunger comprises a plunger seal and plunger rod, wherein the plunger rod is used to move (slide) the plunger seal along the inner surface of the syringe barrel, and wherein the plunger seal maintains a sterile seal when inner surface of the plunger barrel or when being moved (slid) along the inner surface of the syringe barrel,   and wherein one or more of the sequence of steps set forth in the instructions require use of an incubating rocker that operates at a temperature of 37° C. and at a tilt-level of 6 for twenty minutes.