EP-4737553-A2 - SYSTEM AND METHOD FOR BIOPSY PROCESSING

Abstract

A system for digesting a biopsy sample. The system comprises: a vial configured to receive the biopsy sample and a transport fluid, a cap coupled to the vial, the cap comprising a movable tube having an aspiration tip at a distal end, a tube gripper configured to engage a neck of the movable tube and move the movable tube up and down within the vial, an input syringe pump configured to pump air into the vial through the movable tube and to supply a wash fluid and a digest solution to the vial through the movable tube, an output syringe configured to withdraw the transport fluid, the wash fluid, and the digest solution from the vial through the movable tube, a fluid reservoir operably coupled with the input syringe pump, a sensor configured to detect solids in the fluid withdrawn by the output syringe, and a controller configured to control the movement of the tube gripper, the input syringe pump, and the output syringe.

Inventors

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

Assignees

• DEKA Products Limited Partnership

Dates

Publication Date

20260506

Application Date

20240322

Claims (7)

1. A system for digesting a biopsy sample, comprising: a vial configured to receive the biopsy sample and a transport fluid; a cap coupled to the vial, the cap comprising a movable tube having an aspiration tip at a distal end; a tube gripper configured to engage a neck of the movable tube and move the movable tube up and down within the vial; an input syringe pump configured to pump air into the vial through the movable tube and to supply a wash fluid and a digest solution to the vial through the movable tube; an output syringe configured to withdraw the transport fluid, the wash fluid, and the digest solution from the vial through the movable tube; a fluid reservoir operably coupled with the input syringe pump; a sensor configured to detect solids in the fluid withdrawn by the output syringe; and a controller configured to control the movement of the tube gripper, the input syringe pump, and the output syringe.
2. The system of Claim 1, wherein the controller is configured to execute a recovery procedure when the sensor detects solids in the fluid withdrawn by the output syringe, the recovery procedure comprising providing additional fluid to the vial from the fluid reservoir to return the solids to the vial.
3. The system of Claim 1, wherein the vial is configured to receive a biopsy sample from a digestive organ.
4. The system of any of the preceding claims, wherein the cap further comprises a valve that controls the flow of fluid through the movable tube.
5. The system of any of the preceding claims, wherein the controller is further configured to agitate the vial by moving the tube gripper in a circular motion.
6. The system of any of the preceding claims, wherein the controller is further configured to centrifuge the vial to separate the cells from the digest solution.
7. The system of any of the preceding claims, wherein the sensor is an optical sensor that detects the presence of solids by measuring the light transmittance of the fluid.

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