RU2761047C1 - Device for preparing donor fecal material for transplantation - Google Patents

Abstract

FIELD: medical technology.

SUBSTANCE: invention relates to medical technology. The device contains a mixing chamber with a dispersion and homogenization mechanism, a container for a solution, a pump for supplying a solution to the mixing chamber, a mechanism for moving the mixture from the mixing chamber to a filter element with an outlet and a control unit. Additionally, a liquid flow sensor connected to the control unit is introduced, installed between the mixing chamber and the solution container, a solution volume sensor installed in the solution container, and an electric motor installed with the ability to rotate the filter element. The filter element contains mesh cylinders. The control unit is configured to control the start of the supply of a given volume of solution from the container under the control of the liquid flow sensor into the mixing chamber; starting dispersion and homogenization in the mixing chamber; by starting the supply of the dispersed and homogenized suspension from the mixing chamber to the filter element and starting the filtration of the suspension by turning on the electric motor, which drives the mesh cylinders into rotation at a given time and speed.

EFFECT: ensuring a greater yield and better quality of a graft from donor fecal material for the treatment of coloproctological diseases.

3 cl, 1 dwg

Description

The proposed invention relates to the field of medicine, namely to gastroenterology, coloproctology and is intended to obtain various compositions of fecal material from donor feces for its subsequent transplantation to a patient in the treatment of diseases such as ulcerative colitis, Crohn's disease, antibiotic-associated colitis, incl. pseudomembranous, and in conditions where fecal transplantation may be recommended.

Known methods for producing compositions of fecal flora and a device for their delivery (Application No. 2013109251, Russian Federation, IPC A61K 35/12. Composition for transplantation of fecal flora and methods for their preparation and use and devices for their delivery / applicant BORODI Thomas Julius (AU), author BORODI Thomas Julius (AU); LLC "Law Firm Gorodissky and Partners. - convention. priority: 04.08.2010 AU 2010903474; publ. 09/10/2014, bul. No. 25). The known device contains a bag or container with an outlet, functionally connected to the proximal end of a flexible tube or equivalent, an open or closed valve or equivalent or locking screw plug at the distal end of a flexible tube or equivalent, and a pump for moving material in a bag or container through a flexible tube or equivalent from the distal end or from an open or closed valve or equivalent The device further comprises fecal material or a composition thereof.

The disadvantages of this device include the fact that it is not intended to prepare donor material for transplantation, but only serves to deliver the finished mixture to the patient.

The closest in technical essence to the proposed device is a device for preparing donor fecal material for transplantation, containing a mixing chamber connected to a container for a solution, with a pump for supplying a solution to a mixing chamber, with a mechanism for moving the resulting mixture from the mixing chamber to a filter element and a block control connected to each element of the device. The mixing chamber contains a mechanism for dispersing and homogenizing donor fecal material, and the filter element contains a housing inside which contains a filter and a wringing mechanism, while an outlet is made in the lower part of the housing (Pat. No. 2659417, Russian Federation, IPC A61K 35/12, А61J 3/00 Device for preparation of donor fecal material for transplantation, authors: Apartsin K.A., Kulundukov A.A., Chashkova E.Yu .; applicants and patentees: Federal State Budgetary Scientific Institution "Irkutsk Scientific Center of Surgery and Traumatology", Federal State Budgetary Institution Research Center SB RAS - No. 2017122089/15; application filed 22.06.2017; published 02.07.2018; bulletin No. 19).

The disadvantages of the known device include the impossibility of full isolation of fecal microbiota from the donor sample, due to blockage of the filter element mesh and the lack of its tightness and, as a result, there is no necessary pressure to push out the fecal suspension under the action of the wringing mechanism.

In addition, the purification of fecal suspension in the known device is carried out using one filter mesh, which does not provide complete removal of insoluble fecal elements from the prepared transplant.

Also, the disadvantages of the known device include the absence of a fluid flow sensor and a solution volume sensor, which does not allow automating the process and does not guarantee obtaining a fecal transplant with stable parameters.

In addition, the disadvantages of the known device should also include the lack of automation of the manufacturing process of fecal transplant, which also affects the properties of the resulting transplant, due to the impossibility of strict implementation of the pre-laid down preparation algorithm.

The objective of the proposed technical solution is the development of a device for preparing donor fecal material for transplantation, which makes it possible to eliminate the above disadvantages of the known technical solution.

The technical result of the proposed device is to increase the efficiency of its work, by improving the quality of cleaning fecal transplant, increasing the yield of the finished transplant, reducing the preparation time and ensuring the automation of the process according to predetermined parameters of consistency and volume.

The technical result of the proposed device for preparing donor fecal material for transplantation is achieved by the fact that it contains a mixing chamber with a dispersing and homogenizing mechanism, a container for a solution, a pump for feeding a solution into the mixing chamber, a mechanism for moving the mixture from the mixing chamber to a filter element with an outlet, and Control block.

The difference between the proposed device lies in the fact that a liquid flow sensor connected to the control unit is additionally introduced, installed between the mixing chamber and the solution container, a solution volume sensor installed in the solution container, and an electric motor installed with the ability to rotate the filter element.

The distinctive features of the claimed device include the fact that the filter element contains mesh cylinders, and the control unit is configured to control the start of the supply of a given volume of solution from the container under the control of the liquid flow sensor into the mixing chamber; starting dispersion and homogenization in the mixing chamber; by starting the supply of the dispersed and homogenized suspension from the mixing chamber to the filter element and starting the filtration of the suspension by turning on the electric motor, which drives the mesh cylinders into rotation at a given time and speed.

Also, the distinctive features of the proposed device include the fact that the filter element includes a housing, inside which mesh cylinders are installed, placed one in the other, having cells of various dimensions and fixed with the possibility of rotation around their axis.

In addition, the distinguishing features of the proposed device include the fact that the control unit contains a microcontroller.

Comparative analysis of the proposed technical solution and the prototype shows that the proposed device is structurally different from the known one, which allows us to conclude that it meets the criterion of the invention "novelty".

The installation of a liquid flow sensor between the mixing chamber and the solution container, as well as the installation of a solution volume sensor in the solution container, makes it possible to obtain a fecal transplant with predetermined consistency and volume parameters.

The connection of the filter element with the electric motor provides the possibility of rotation at a given speed of the mesh cylinders placed inside its housing.

The number of mesh cylinders placed one in the other in the body of the filter element, as well as the different dimensions of the mesh of the mesh cylinders and the possibility of their rotation around their axis, make it possible to obtain a fecal transplant with desired properties in terms of consistency and volume. In this case, the mesh cylinder for coarse cleaning has the largest cell size, and in each subsequent cylinder the cell size decreases. This makes it possible to effectively purify the fecal suspension from all insoluble fecal elements, regardless of their size, thereby preventing blockage of the cells and achieving the maximum yield of the finished fecal transplant.

The use of an electric drive to rotate the mesh cylinders around its axis inside the sealed housing of the filter element allows the action of centrifugal force to separate the fine fractions from the coarse impurities of indigestible fiber and achieve a more complete extraction and improve the quality of purification of fecal transplant from the suspension.

When using the proposed device, the yield of the finished graft reaches 80-92.5%, and in the known device 65-67.5%, namely: from 400 ml of the initial volume of the donor biomaterial 320 - 370 ml of the graft is obtained, and when using a known device from such the same volume of the initial biomaterial received 260-270 ml.

The use of a given speed of rotation of several mesh cylinders with a decreasing size of their cells makes it possible to intensify the process of filtration of fecal suspension.

The use of a microcontroller in the control unit makes it possible to automate the preparation of fecal transplant according to a given algorithm.

In the available literature, the authors have not identified a device for the preparation of donor fecal material for transplantation, which has the distinctive features of the proposed technical solution.

Distinctive features of the proposed device provide the ability to obtain the specified technical result, namely to increase the efficiency of its work, due to:

- improving the quality of cleaning fecal transplant from impurities of indigestible fiber,

- increasing the yield of the finished graft from the donor sample,

- shortening the preparation time for the graft from 30 minutes to 15 minutes, which makes it possible to reduce the time of contact of the biomaterial with the aerobic environment,

- ensuring the automation of the process according to predetermined parameters of consistency and volume,

- complete elimination of the influence of external factors on the process of preparation of the graft due to the isolation of all nodes and mechanisms of the device.

The above advantages and differences allow us to conclude that the proposed device meets the criterion of "inventive step".

The device for preparing donor fecal material for transplantation, which constitutes the claimed invention, is intended for use in medicine and can be used in coloproctology, gastroenterology, surgery and related specialties in the treatment of diseases such as ulcerative colitis, Crohn's disease, antibiotic-associated colitis, severe or recurrent pseudomembranous colitis, as well as in conditions where fecal transplantation is recommended, therefore, the proposed technical solution meets the criterion of the invention "industrial applicability".

The essence of the invention is illustrated by figure 1, which shows a schematic diagram of the proposed device, where: 1 - donor biomaterial (feces), 2 - mixing chamber with homogenization and dispersion mechanisms, 3 - solution container, 4 - pump, 5 - flow sensor liquids, 6 - solution volume sensor, 7 - compressor, 8 - homogenized fecal suspension, 9 - filter element, 10 - mesh cylinders, 11 - electric motor, 12 - filtered graft, 13 - outlet, 14 - control unit.

The proposed device for the preparation of donor fecal material for transplantation works as follows: the donor biomaterial (feces) 1 is placed in a mixing chamber 2 with a homogenization and dispersion mechanism, after which from the solution container 3 by means of pump 4 and under the control of a fluid flow sensor 5 and a sensor volume of solution 6, the solution is fed into mixing chamber 2.

In the process of mixing the donor 1 biomaterial with a solution or with other means and media, the composition is dispersed and homogenized.

Then, under the action of a movement mechanism, for example a compressor 7, the resulting homogenized fecal suspension 8 from the mixing chamber 2 moves to the filter element 9, consisting of a housing and filtering mesh cylinders 10 (with different mesh dimensions). Under the action of centrifugal forces generated by the electric motor 11, the fecal suspension 8 is filtered through the mesh cylinders 10 of the filter element 9. The filtered graft 12 through the outlet 13 in the housing of the filter element 9 enters the accumulator (not shown in the figure). Depending on the solution of specific tasks, the storage device can be represented by a sterile vessel, container or container, or a sterile sealed bag or hema-cone.

All electrical elements of the claimed device are controlled by the control unit 14, which allows the following program to be carried out according to a given algorithm:

• starting the process of supplying a given volume of solution from the tank 3 under the control of the liquid flow sensor 5 into the mixing chamber 2;

• starting the process of dispersion and homogenization of the donor biomaterial 1 in the mixing chamber 2 according to the specified parameters - the duration and intensity of mixing;

• starting the process of feeding dispersed and homogenized fecal suspension 8 from the mixing chamber 2 using the compressor 7 into the filter element 9;

• starting the filtration process of the crude homogenized fecal suspension 8 by turning on the electric motor 11, which drives the mesh cylinders 10 into rotation according to the specified parameters - the time and speed of rotation;

• control unit - 14 independently ends the program according to the given algorithm.

The authors of the proposed technical solution made a prototype of the claimed device. Using it in practice has shown:

• the possibility of obtaining a fecal transplant in an automatic mode with minimal human involvement;

• the possibility of mixing fecal masses with various solutions and media to achieve the required properties of the composition;

• sanitary and hygienic benefits due to lack of odors and personnel contact with donor material.

The study obtained using the proposed device samples of fecal transplants was carried out in the laboratory of the Department of Clinical Surgery of the Institute of Chemotherapy.

When using the proposed device, 10 samples of fecal transplants were obtained, the volume of which, depending on the initial volume of the donor biomaterial, ranged from 320 ml to 370 ml.

The settling of fecal transplant samples for 3 hours from the moment of preparation showed that none of them contained a sediment formed by the components of plant fiber. The resulting fecal graft had a homogeneous structure. When the graft was introduced into the endoscope canal, no difficulties in its advancement along the canal, clogging of the canal or violations of evacuation from the endoscope canal were found in any of the 10 test specimens.

Laboratory study of the microbial composition of both fresh native donor material and prepared from it (on the proposed device) prototypes of fecal transplant showed their complete identity.

The entire process of preparing a fecal transplant from native biomaterial takes 15 minutes. In this case, the process of the proposed device is fully automated.

The advantages of the proposed device should also include the lack of smell of the used biomaterial during the preparation of fecal transplants.

Thus, the proposed device makes it possible to prepare a transplant from a donor fecal material that is completely ready for use for therapeutic purposes.

Claims (3)

1. A device for preparing donor fecal material for transplantation, containing a mixing chamber with a dispersing and homogenizing mechanism, a container for a solution, a pump for supplying a solution to the mixing chamber, a mechanism for moving the mixture from the mixing chamber to a filter element with an outlet and a control unit, which is characterized by that additionally a fluid flow sensor connected to the control unit is introduced, installed between the mixing chamber and the solution container, a solution volume sensor installed in the solution container, and an electric motor installed with the ability to rotate the filter element, while the filter element contains mesh cylinders, and the control unit is configured to control the start of the supply of a predetermined volume of solution from the container under the control of the liquid flow sensor into the mixing chamber; starting dispersion and homogenization in the mixing chamber; by starting the supply of the dispersed and homogenized suspension from the mixing chamber to the filter element and starting the filtration of the suspension by turning on the electric motor, which drives the mesh cylinders into rotation at a given time and speed. 2. A device according to claim 1, characterized in that the filter element includes a housing, inside which mesh cylinders are installed, placed one in the other, having cells of various dimensions and fixed with the possibility of rotation around their axis. 3. The device according to claim 1, wherein the control unit contains a microcontroller.

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