EP-4737554-A2 - SYSTEM AND METHOD FOR BIOPSY PROCESSING

Abstract

A system for processing a biopsy containing cells is disclosed. The system comprises: a biopsy vial configured to contain a biopsy tissue and a transport fluid and having a transport cap, a replacement cap to replace said transport cap, said replacement cap having a movable tube extending therethrough, a fluid supply subsystem, and a tubing cassette fluidically connecting said fluid supply subsystem to said movable tube.

Inventors

• WHITE, MATTHEW
• KIM, KEVIN
• FINSETH, Bryan A

Assignees

• DEKA Products Limited Partnership

Dates

Publication Date

20260506

Application Date

20240322

Claims (12)

1. A system for processing a biopsy containing cells, comprising: a biopsy vial configured to contain a biopsy tissue and a transport fluid and having a transport cap; a replacement cap to replace said transport cap, said replacement cap having a movable tube extending therethrough; a fluid supply subsystem; and a tubing cassette fluidically connecting said fluid supply subsystem to said movable tube.
2. The system of claim 1, further comprising: a user interface for adjusting operating parameters, controlling the process and providing reporting on the process.
3. The system of claim 1 or claim 2, wherein said biopsy vial, said replacement cap, said fluid supply subsystem and said tubing cassette are connected to form a closed sterile loop.
4. The system of claim 3, further comprising: at least one pump to move fluid within said closed loop.
5. The system of claim 4, wherein said at least one pump is a syringe pump.
6. The system of claim 4, wherein said at least one pump is two syringe pumps.
7. The system of any preceding claim, further comprising: a biopsy vial subsystem including: said biopsy vial; said replacement cap with said movable tube therein; a gripper engaged with said movable tube; an actuator for movement of said gripper; sensors; and an agitator.
8. The system of claim 7, wherein the sensors are laser sensors configured for monitoring the position of the biopsy vial movable tube and to detect the presence of solids among the liquid passing through biopsy vial movable tube.
9. The system of claim 8, configured to execute a solid recovery operation when a solid is detected.
10. The system of any preceding claim, the fluid supply subsystem further comprising: a fluid bag mount supporting a plurality of fluid bags.
11. The system of claim 10, the fluid supply subsystem further comprising: thermal control elements configured to maintain said fluid bags at a predetermined temperature.
12. The system of any preceding claim, the tubing cassette further comprising: a cassette body having a tubing path therein; a closed tubing loop within said tubing path; openings within said cassette body that position said closed tubing loop such that it is over and accessible to a plurality of pinch valves.

Description

BACKGROUND The present disclosure pertains generally to autologous cell therapy. More specifically, the present disclosure relates to automated cell preparation for use in various autologous cell therapy procedures. Autologous cell therapy (ACT) is a therapeutic intervention that uses an individual's cells, which are biopsied, cultured and expanded outside the body, the reintroduced into the donor for treatment. ACT provides for a minimization of risks associated with the use of donor tissues such as systemic immunological reactions, bio-incompatibility, and disease transmission associated with grafts or cells not cultivated from the individual. To date, ACT has been used successfully to bioengineer skin substitutes, aid wound healing, counteract chronic inflammation, treat burns and pressure ulcers, and improve postoperative healing. Further, ACT has been used to enhance the healing process of conditions such as a damaged myocardium, developing hyaline cartilage, and in the treatment of neurodegenerative diseases and other ailments that benefit from the immediate availability of a donor. The use of ACT for cosmetic enhancement or corrective surgery is also gaining recognition as a creditable form of treatment and has been shown to reduce the risk of rejection and to have longer lasting effects than conventional treatments. This form of treatment is under intense investigation with the hope that it will eventually be able to replace conventional forms of plastic surgery to improve the repair process of aging or damaged tissues. Over the past few decades, since the bioengineering revolution, autologous cell therapy has become a rapidly evolving field. From the discovery of plasmids as vectors for bulk protein cultivation in 1973, and the production of recombinant human insulin in 1978, to the construction of the world's first artificial cornea in 1999, biosynthetic solutions to human conditions have been of great revelation and interest in the scientific industry. One of the greatest success stories of modern medicine has been the advent of organ transplantation. As life expectancy in the developed world increases, the expiration of body tissues and organs through attrition, disease, or even trauma, is inevitable. Despite its ability to either restore a normal standard of living or extend life, organ transplantation is plagued with its fair share of problems. Almost a victim of its own success, the body's immune system can sometimes recognize the foreign entity and reject the new tissue or organ regardless of patient matching and immunosuppressive drugs. Such consequences and shortages in supply have increased interest in regenerative and autologous therapies. Although many cells respond to signaling and stimuli in the body, they can also be cultivated outside the human body in Petri dishes and culture flasks. Tissue engineering techniques allow cell types to be grown in isolation using defined media for optimal growth. Such a capacity allows for the culture and study of cells more closely and independently of the organ from which they are a part. More impressively, this enables a small number of cells taken from an individual to be expanded outside the body and reintroduced into the donor for therapeutic intervention. The scope for ACT is vast and has immense potential for rejuvenation. Much of this form of therapy is currently under investigation or in clinical trials. These include the treatment of limb ischemia, bone marrow mononuclear cell transplantation treatment for acute radiation victims, ischemic stroke and ischemic heart disease, cell-mediated immunotherapy after chemotherapy, autologous hematopoietic cells as targets for gene transfer to treat various blood disorders and autoimmune diseases, the use of autologous macrophages to treat acute complete spinal cord injury, cell therapy with autologous lymphocytes to treat various cancers, cell therapy for inner ear cell degeneration, and autologous serum for treatment of ocular disorders. Some of the challenges facing any cellular transplant include, the ability of the cells to integrate and function alongside resident cells without interfering with other cells or cellular reactions. The major disadvantage of using allogeneic grafts or transplants from non-self is the possibility of systemic immunological reactions. At best, such a response could be uncomfortable and at worst life-threatening, either of which would require a lifetime of immunosuppressive drug therapy. Another concern is the risk of disease infection from animal transplants; for example, porcine endogenous retrovirus (PoERV) has caused concerns with xenotransplantation. Present in the genome of all pigs, this virus is genetically transmitted and is able to infect human cells. Concerns surround the release of the virus from the xenograft, subsequent infection of host cells, and eventual production of lymphomas. Commercial demands for any biotechnological practice require that the proce