RU-2861675-C1 - METHOD FOR PREPARING DONOR FAECAL MICROBIOTA FOR TRANSPLANTATION AND DEVICE FOR IMPLEMENTING SAME

RU2861675C1RU 2861675 C1RU2861675 C1RU 2861675C1RU-2861675-C1

Abstract

FIELD: medicine; medical technology. SUBSTANCE: invention is intended for processing donor faecal material into a faecal microbiota preparation ready for transplantation into a recipient and can be used in clinics specialising in surgery, gastroenterology and coloproctology, and infectious diseases. The method for preparing donor faecal microbiota for transplantation includes collecting the donor material into a container of the device for preparing donor faecal microbiota for transplantation, sealing the device container, transporting the device to the point of further material processing and/or to the patient's location, dosed supply of saline solution into the container, mixing the donor material with the saline solution, filtering the resulting suspension and filling containers for faecal microbiota for subsequent transplantation. The saline solution is pre-saturated with carbon dioxide and a dosed amount of this solution is supplied into the container of the device for preparing donor faecal microbiota for transplantation immediately before sealing it, and the mixing of the donor material with the saline solution begins directly during the transportation of the device. EFFECT: simplifying and reducing the time for preparing the material for transplantation, allowing the donor material to be prepared for transplantation both when it is possible to transport the donor material to a specialised laboratory and when such a possibility is absent. 2 cl, 2 dwg

Inventors

Shelekhov Nikita Alekseevich
ERMAKOV VYACHESLAV ALEKSEEVICH
Luts Yurij Vladimirovich
Apartsin Konstantin Anatolevich

Dates

Publication Date: 20260507
Application Date: 20250105

Claims (2)

1. A method for preparing donor fecal microbiota for transplantation, which includes collecting donor material in a container of a device for preparing donor fecal microbiota for transplantation, sealing the container of the device, transporting the device to a point for further processing of the material and (or) to a point where the patient is located, metered supply of a physiological solution into the container, mixing the donor material with the physiological solution, filtering the resulting suspension and filling containers for fecal microbiota for subsequent transplantation, characterized in that the physiological solution is pre-saturated with carbon dioxide and a metered amount of this solution is supplied to the container of the device for preparing donor fecal microbiota for transplantation immediately before sealing it, and mixing of the donor material with the physiological solution begins directly during the transportation of the device.
2. The method according to paragraph 1, characterized in that the mixing of the donor material with the physiological solution is carried out by, for example, applying alternating loads to the device and (or) by rotating the device with a periodic change in the direction of rotation.

Description

The invention relates to medicine and medical technology and is intended for processing fecal donor material into a fecal microbiota preparation ready for transplantation into a recipient. This preparation is used for therapeutic or prophylactic effects on the human body, or for replacing or correcting the functions of organs and body systems. The invention can be used in clinics specializing in surgery, gastroenterology, proctology, and infectious diseases. A method for preparing donor fecal microbiota for transplantation is known, which includes collecting donor material in a container, mixing the donor material with a saline solution, and filtering the resulting suspension (see, for example, https://journal.tinkoff.ru/peresadka-kala/). This method has limited application, particularly due to the rapid degradation of microbiota under the influence of atmospheric oxygen during the preparation of donor fecal microbiota for transplantation and delivery from donor to recipient. A method for preparing donor fecal microbiota for transplantation is also known, which includes collecting donor material in a device with a container in which the air is replaced by an inert, non-reactive gas or gases, while options are provided for mixing the donor material with a physiological solution (homogenization) and filtering the resulting suspension (see Russian patent application No. 2013109251 published 10.09.2014). The method reduces the degradation of microbiota during the preparation of donor fecal microbiota for transplantation and transportation to the point of further processing of the material and/or to the patient's location; however, the preparation of the microbiota and transportation are carried out using different devices, which significantly complicates and lengthens the process. The closest to the proposed method is a method for preparing donor fecal microbiota for transplantation, which includes collecting donor material in a container of a device for preparing donor fecal microbiota for transplantation, sealing the container of the device, creating an anaerobic environment, for example, using carbon dioxide, transporting the device to a point for further processing of the material and/or to the patient's location, metering the supply of a solution into the container, mixing the donor material with the solution, filtering the resulting suspension and filling containers for fecal microbiota for subsequent transplantation (RU Patent No. 2745125, published March 22, 2021). This method allows for the preparation of donor fecal microbiota for transplantation directly in the device's sealed container (donor container), eliminating personnel contact with the donor material and contamination of surrounding equipment with donor fragments. However, due to the complex equipment involved, including peristaltic pumps with tubes and filters, this method requires a specialized laboratory, which is typically located only in large population centers. This means that, depending on the location of the donor, the specialized laboratory, and the patient, the patient's wait time for the donor material may be unreasonably long. A device for delivering fecal material or composition is known, which contains a bag or container with an outlet (application RU 2013109251 published 10.09.2014). The disadvantages of this device include the fact that it is not intended for preparing donor material for transplantation, but is used only to deliver the prepared mixture to the patient. A device for transporting and preparing donor fecal microbiota for transplantation is also known. It comprises a container with a sealed lid and at least one port for supplying a solution and/or gas, a means for homogenizing the container's contents, and a port for removing the contents for further processing of the transplant (Russian Federation Patent No. 2745125, published March 22, 2021). This device is the closest to the proposed one and is considered a prototype. The device allows for optimal conditions for preserving the microbiota during the transport of donor material to a specialized laboratory and preparation for transplantation. However, this device can only be used if it can be transported to a specialized laboratory, which prevents the immediate delivery of donor material directly from the donor to the patient in emergency cases while simultaneously preparing the donor material for transplantation. The objective of the inventions is to simplify the equipment of a specialized laboratory without deteriorating the quality of preparation of material for transplantation, to reduce the time of its preparation and to achieve the possibility of preparing donor material for transplantation both when it is possible to transport donor material to a specialized laboratory and when such a possibility is not possible for any reason. In order to obtain such a technical result in the proposed method for preparing donor fecal microbiota for transplantation, which i