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EP-4735181-A1 - IMPROVED CRUSHING DEVICE IN AN ISOLATED ENVIRONMENT

EP4735181A1EP 4735181 A1EP4735181 A1EP 4735181A1EP-4735181-A1

Abstract

The improved crushing device (1) comprises a cylindrical body (2) with a port (2A) for loading and containing the material to be treated; a pressure piston (5) is sliding, in the operational configuration, within the cylindrical body (2) so as to push and compress the loaded material against a drawing baffle (6), or sieve; still in the operational configuration, a cutting device (7) also operates on the material to be treated and is configured to rotate and make micro-fragmentations with the cutting action exerted by one or more rotating blades and the simultaneous thrust by the pressure piston (5); the device is hermetically closable by means of a closing bottom (8) in turn comprising a passageway and a hydraulic connection (10) to allow the treated material to be attached and thus extracted directly as a result of the action of the pressure piston (5) and of the cutting device (7).

Inventors

  • BOSETTO, ANTONIO
  • PIRAZZOLI, PAOLO

Assignees

  • Hydra Srl

Dates

Publication Date
20260506
Application Date
20240627

Claims (17)

  1. 1) Improved crushing device (1), characterized by the fact that it comprises a cylindrical body (2) with a port (2A) for loading and containing the material to be treated; a pressure piston (5) is sliding, in the operational configuration, within said cylindrical body (2) so as to push and compress the loaded material against a drawing baffle (6), or sieve; still in the operational configuration, a cutting device (7) also operates on the material to be treated and is configured to rotate and make micro-fragmentations with the cutting action exerted by one or more rotating blades and the simultaneous thrust by said pressure piston (5); the device is hermetically closable by means of a closing bottom (8) in turn comprising a passageway and a hydraulic connection (10) to allow the treated material to be attached and thus extracted directly as a result of the action of said pressure piston (5) and of said cutting device (7).
  2. 2) Device (1) according to claim 1, characterized by the fact that, once coupled, said loading port (2A) of said cylindrical body (2) is hermetically sealed by said bottom (8) by means of at least one seal (11).
  3. 3) Device (1) according to one or more of the preceding claims, characterized by the fact that the collection of the treated material is carried out by means of a collection device (12) connected to said hydraulic connection (10).
  4. 4) Device (1) according to one or more of the preceding claims, characterized by the fact that said collection device (12) connected to said hydraulic connection (10) makes with said device (1) a substantially hermetically closed system.
  5. 5) Device (1) according to one or more of the preceding claims, characterized by the fact that said drawing baffle (6), or sieve, is positioned in the proximity of said port (2 A) of said cylindrical body (2), in a special seat formed on said bottom (8).
  6. 6) Device (1) according to one or more of the preceding claims, characterized by the fact that it comprises an anti-rotational system of said pressure piston (5) made by means of a slider on said cylindrical body (2) and one or more pins locked together with the same pressure piston; said pin also serving as an indicator of the position of the stroke of the same pressure piston.
  7. 7) Device (1) according to one or more of claims 1 to 5, characterized by the fact that it comprises an anti-rotational system of said pressure piston (5) made by means of a coupling of the “male-female” type and implemented in an axial cavity formed on said pressure piston (5) configured to engage a corresponding tab formed on the inner skirt of said cylindrical body (2) within which it slides.
  8. 8) Device (1) according to one or more of the preceding claims, characterized by the fact that it is made, at least partly, of transparent, semitransparent and/or opaque material to enable the interior of said device (1) to be inspected in the operational configuration.
  9. 9) Device (1) according to one or more of the preceding claims, characterized by the fact that said pressure piston (5) defines a thrust chamber (15) of the material to be treated towards said port (2A) and/or said drawing baffle (6) and by the fact that said device (1) comprises a single thrust chamber (15).
  10. 10) Device (1) according to one or more of the preceding claims, characterized by the fact that said hydraulic connection (10) is made axially on said bottom (8).
  11. 11) Device (1) according to one or more of the preceding claims, characterized by the fact that said bottom (8) comprises a fixed bottom wall (19) arranged, in the operational configuration, substantially facing said drawing baffle (6), or sieve, to receive the treated material.
  12. 12) Device (1) according to one or more of the preceding claims, characterized by the fact that said hydraulic connection (10) is made on said bottom wall (19).
  13. 13) Device (1) according to one or more of the preceding claims, characterized by the fact that said bottom wall (19) has a substantially sloping conformation and converging towards said hydraulic connection (10) to convey the treated material towards the latter.
  14. 14) Device (1) according to one or more of the preceding claims, characterized by the fact that said hydraulic connection (10) is made at the center of said bottom (8).
  15. 15) Device (1) according to one or more of the preceding claims, characterized by the fact that it comprises driving means (20) kinematically connected to said cutting device (7) and to said pressure piston (5), said driving means (20) being adapted to move said cutting device (7) in rotation and said pressure piston (5) by sliding.
  16. 16) Device (1) according to one or more of the preceding claims, characterized by the fact that said driving means (20) defines a bearing base (21) arranged, in use, resting on a stable surface. 17) Device (1) according to one or more of the preceding claims, characterized by the fact that said driving means (20) comprise a revolving handwheel (22) provided with a plurality of spokes (23) defining said bearing base (21). 18) Device (1) according to one or more of the preceding claims, characterized by the fact that said driving means (20) are arranged opposite said port (2A), so as to facilitate the access to the latter by means of a user with said bearing base (21) arranged resting on the stable surface. 19) Device (1) according to one or more of the preceding claims, characterized by the fact that said drawing baffle (6) (sieve) is arranged within said device (1), dividing it into: a first chamber (13), on the side of the cylindrical body (2), of variable volume during operation and serving as a loading and containing zone for the material to be treated, and a second chamber (14), on the side of the bottom (8), of fixed volume and defining said interspace for the passage of the treated material. 20) Device (1) according to one or more of the preceding claims, characterized by the fact that it lacks thrust means, other than said pressure piston (5), operating within said first chamber (13) and said second chamber (14) to push the material to be treated towards said port (2 A) and/or said drawing baffle (6). 21) Device (1) according to one or more of the preceding claims, characterized by the fact that in said operational configuration said thrust chamber (15) coincides with said first chamber (13). 22) Device (1) according to one or more of the preceding claims, characterized by the fact that said second chamber (14), in the operational configuration, extends between said drawing baffle (6) and said bottom wall (19). 23) Device (1) according to one or more of the preceding claims, characterized by the fact that it comprises a screw (4) driving the pressure piston (5) and/or the cutting device (7) and by the fact that: said cylindrical body (2) comprises a base portion (3) provided with a hole
  17. (17) and arranged opposite said end (2A) and a connecting portion (18) connecting said base portion (3) to said end (2A), said base portion (3) being made in a single body piece with said connecting portion (18); said screw (4) is inserted within said cylindrical body (2) through said hole (17).

Description

IMPROVED CRUSHING DEVICE IN AN ISOLATED ENVIRONMENT Technical Field This invention relates to a fragmentation device for the treatment of a biological material, particularly adipose tissue. Background Art Adipose-derived stem cells (ADSCs) are mesenchymal stem cells which are able to renew themselves through mitotic cell division and to differentiate into a wide range of specialized cell types. As cells that exist abundantly in the SVF (stromal vascular fraction) of adipose tissue, they are ideal as a cell source in the field of regenerative medicine. ADSCs can be obtained from fat deposits and collected from adipose tissue through a simple minimally invasive collecting procedure performed by a surgeon under general or local anesthesia. Recent investigations suggest that ADSCs and the stromal vascular fraction (SVF, which consists of connective stroma with a supporting function for adipocytes and blood vessels) are easily isolated from the human adipose tissue, removed surgically or by liposuction, by means of enzymatic digestion. In order to obtain ADSCs and SVFs, enzymatic digestion is used, which allows a large number of cells to be obtained rapidly. However, European legislation considers enzymatic digestion as substantial manipulation; this is feasible but is considered “major manipulation” and, therefore, subject to more stringent regulations than a one- step intervention (explantation and implantation at the same surgical time) with only mechanical treatment of the tissue. Another well-known method is to isolate tissue micro-grafts using a centrifugation technology that consists in making the adipose tissue to be treated rotate within a container. Using a grid in the device, fragments are selected within which the portion of progenitor cells is statistically significant. Other techniques of known type may involve filtration and/or sedimentation. Description of the Invention The object of the invention is to develop an improved device which is able to effectively micro-fragment soft tissue under sterile conditions. The invention consists of a closed system so that the biological material is not exposed to external environmental contamination before being re-implanted. In order to implement the aforementioned object, the device comprises a cylindrical body and a bottom which, in the operational configuration or operational conditions are coupled in a sealing manner so as to define an inner chamber; a drawing baffle (sieve) is placed within the device so as to divide the interior into two volumes: the first volume and/or the larger volume, on the cylindrical body side, to contain the material to be treated while the second volume and/or the smaller volume, on the bottom side, to pass the treated material towards the collection device. The bottom is also configured with a hydraulic connection or connector, preferably central, configured to receive in turn a collection device, such as e.g. a collection syringe, of the material. Therefore, the second volume, the one on the bottom side, serves as a passage space (interspace) to allow the outflow towards the collection device connected to the connector which, preferably, is of the Luer type. Thus, while grinders of the prior art allow multiple passages, transferring the material to be treated between two chambers, this improved device allows reducing dead volumes and performing the transfer, from the containment chamber to the collection device into a sterile closed loop via a direct connection, with only one passage, sufficient for most soft tissues. In fact, within the cylindrical body there is a pressure piston and a related cutting device or knife configured to rotate and make micro fragmentations of the material to be treated, under the combined thrust action by the related pressure piston. According to a preferred embodiment of the invention, the pressure piston is made to move forward by a screw coaxial to the cylindrical body. The material to be treated is thus introduced into the compartment between the baffle and the pressure piston then, as a result of the closure of the device, of the actuation of the rotating knife and of the movement of the related pressure piston, is transferred, passing through the drawing baffle and the interspace in the bottom, to the collection device to be used for specific therapy or laboratory purposes. Precisely, after loading, everything is carried out in just one step: the material is pushed by the pressure piston moving forward through the screw, is crushed by the knives, extruded through the sieve and pushed into the interspace and therefrom into the collection device through the connector. In fact, as mentioned, the bottom comprises a hydraulic connection adapted to allow the extraction or discharge of the treated material. According to one aspect of the invention, the connection can be closed by a small plug; under operational conditions, the hydraulic connection is normally engaged by the collection device.