WO2015149098A1

WO2015149098A1 - Device for the withdrawal and portioning of fatty tissue

Info

Publication number: WO2015149098A1
Application number: PCT/AT2015/050079
Authority: WO
Inventors: Hajnal KIPROV
Original assignee: Liporegena Gmbh
Priority date: 2014-03-31
Filing date: 2015-03-27
Publication date: 2015-10-08

Abstract

The invention relates to a device (1) for the withdrawal and portioning of fatty tissue, with an aspiration needle (2) and, connected to the latter via a hose (3), a collecting container (4), and a hose pump (5) that can be disposed on the hose (3). To permit the portioning of the withdrawn fatty tissue under sterile conditions, without the need for a sterile room, the collecting container (4) is connected, by way of a connection element (6) with a shutoff member (7), to a liquid container (8) for receiving a liquid that settles by gravity from the fatty tissue in the collecting container (4), and the collecting container (3) is connected by way of further connection elements (6) to at least one portioning container (9), wherein the aspiration needle (2), the hose (3), the collecting container (4), the liquid container (8), the at least one portioning container (9) and the connection elements (6) are fluidically connected to one another to form a closed sterile system and are arranged in a sterile package (10).

Description

Apparatus for removing and portioning fatty tissue

The invention relates to a device for removing and Portio ^¬ ning of fatty tissue, with a suction cannula and a thus connected via a hose collecting container, on which

Hose a hose pump can be arranged.

Recently, efforts are being made from adipose tissue to obtain stem cells, which are to be used for a variety of applications to ^¬ future. For example, stem cells can be used for cosmetic purposes, but also to support the treatment of joint diseases or for the therapy of cardiovascular diseases. The extraction of adult stem cells from bone marrow or umbilical cord is stressful and relatively expensive for the patient, so to ^¬ efforts are being made to extract stem cells from adipose tissue.

For example, EP 2,380,970 AI describes a method and a device for obtaining stem cells from different types of tissue, for example from adipose tissue.

The treatment of vascular diseases by means of stem cells is described, for example, in EP 2,348,103 A2. Also in support of wound healing, stem cells are used according to EP 2,332,555 A2.

Known methods for the removal of fatty tissue are usually quite expensive, since the liposuction must be done under sterile conditions, if the fatty tissue is to be used for stem cell production.

The object of the present invention is to provide an abovementioned device for removing and portioning fatty tissue, by means of which at least part of the removed fatty tissue can be used for subsequent reuse, in particular the production of stem cells. The device should be as simple and inexpensive as a disposable product. Additional measures such as the Disposition ^¬ position of a sterile room or clean room are eliminated. Disadvantages of known devices should be avoided or at least reduced.

This object is achieved by an above-mentioned device, wherein the collecting container is connected via a connecting element with a shut-off device with a liquid container for receiving a fat by gravity in the collecting gravity-absent ^¬ zenden liquid, and the collecting container via further connecting elements with at least one Portionierbehäl ^¬ ter is connected, wherein the suction cannula, the tube, the collecting container, the liquid container, the at least one Portionierbehälter and the connecting elements fluid-tight with ^¬ each other to a sterile closed system and are arranged in a sterile packaging. The subject device is characterized by a sterile packaged, sterile, CLOSED ^¬ senes system which ensures the sampling and Portionie ^¬ tion of fatty tissue under sterile conditions. Without the need for a sterile room or clean room can thus be done using the device, the portioning desired amounts of fatty tissue and these portions are supplied to the further utilization. In particular, the filled fat tissue portions can be used for stem cell production and storage at correspondingly low temperatures. The device can be assembled by relatively simple components, which can be replaced by appropriate prior to packaging

Measures such as sterilization, disinfection, pasteurization, heating, chemical applications, or application of gamma rays are sterilized.

In order to be able to collect a sufficient amount of fatty tissue for later further processing, in particular stem cell production, during liposuction, several, preferably three to five, portioning containers are provided. The amount of Portionierbehälter and also their size is adjusted according to the respective requirements. In a removal set several identically sized Portionierbehälter, or portioning container with different volumes, can be arranged.

The collecting container can be connected via a connecting element with a shut-off device with a surplus container, in which excess container after filling all Portionierbehäl ter excess fatty tissue can be transferred.

In the simplest manner, at least one connecting element is formed by at least one piece of hose and at least one connecting piece, which at least one piece of hose and which ^¬ least one connecting piece fluid-tightly connected to each other, preferably glued or welded. By fluiddich te connection of the components a sterile, closed system is achieved, in which no germs penetrate from the outside Kings NEN. Thus, when using this closed, sterile system, it is not necessary to use a sterile room or clean room for liposuction.

The shut-off devices may be formed by hose clamps or solenoid valves. Hose clamps are suitable for simple ma nually operable removal devices, whereas an automatic or teilautoma tables removal and portioning of the fatty tissue can take place when using solenoid valves.

In the case of the use of solenoid valves, each solenoid valve is preferably connected to a control device, wel che control device further with the hose pump

is connectable. Thus, via the control device, an automatic or semi-automatic removal and portioning of the fatty tissue take place by the control device di activation and deactivation of the peristaltic pump and its direction of rotation and the opening and closing of the solenoid valves after egg nem predetermined timing controls. Accordingly, upon removal of the adipose tissue, the peristaltic pump is activated so that carriage of the adipose tissue from the aspiration cannula to the collection container can be accomplished. After completion of the liposuction, a predetermined period of time is waited so that the fluid in the fatty tissue can settle and be transported into the fluid container. Thereafter, the direction of rotation of the peristaltic pump is reversed, so that the fatty tissue can be transported from the sump into the Portionierbehälter. Any excess of adipose tissue can be transported into a possibly existing surplus container become. After the portioning of the fatty tissue in the individual Portionierbehälter these are sealed, for example, welded, and fed to further processing. The other components of the sampling device can then be disposed of.

The collecting container and / or the liquid container and / or the at least one portioning container and / or the excess container is or are preferably formed by a flexible plastic bag. Such flexible Art ^¬ textile bags, such as those used in blood donations are particularly economical to produce.

At least one addition and / or removal opening can be arranged on the collecting container and / or at least on a portioning container. About such addition and / or

Removal openings, which are welded, for example, to the flexible plastic bags, certain substances can be added, or samples are taken for certain investigations.

The addition and / or removal opening can be formed by a closable connection, for example a conventional and standardized Luer-Lock connection in medical applications.

Alternatively or additionally, the addition and / or removal opening can also be formed by a piercing membrane, as is customary in containers for vaccines.

At least one suspension opening is arranged on the collecting container and / or on the liquid container and / or on the at least one portioning container and / or on the excess container. As a result, the handling can be facilitated by the various containers of the sampling device can be hung on a corresponding bracket. a holding device for releasably securing at least a collecting container and / or the liquid container and / or the at least one portioning container and / or the excess container is provided, the handling in the removal and portioning of the fatty tissue can also be further supported. In the simplest case, the holding device can simply be designed with a corresponding number of hooks by means of a linkage connected to a corresponding base. Even more complex embodiments, possibly with electrical and electromechanical components, are also conceivable.

The holding device is preferably configured for attachment of the collecting container above the liquid container so that ^¬ can take place a separation of the liquid portion in the adipose tissue and a transportation from the collection container into the liquid container by utilizing the force of gravity.

The collection container may, for example, have a capacity of 500ml to 2000ml. For the usual applications, such a volume will suffice for the sump. Of course, however, collecting containers with a larger volume are also conceivable.

The at least one portioning container, for example, has a capacity of 10ml to 200ml. This volume has proven to be suitable for obtaining stem cells from adipose tissue. If other processing operations are planned, of course, other sizes for the portioning container can be provided.

A label is preferably arranged on the collecting container and / or liquid container and / or at least on a portioning container and / or excess container. By such labels, which are preferably attached by gluing to the respective container, a clear Zu ^¬ order to the respective patient is possible. The label may contain the name of the patient or a code representing the patient, for example a barcode.

The sterile packaging is preferably tool-less designed to allow rapid removal of the device prior to the removal of fatty tissue. For example, the ste- Rile packaging have a tear tab or tear notch or ^¬ same.

The invention will be explained in more detail with reference to the attached figures. Show:

1 shows a schematic embodiment of a sterile device for removing and portioning fatty tissue in a corresponding packaging;

FIG. 2 shows a device for removing and portioning fatty tissue according to FIG. 1 when used with optional control; FIG.

3 shows a detailed view of two portioning containers of the device for removing and portioning fatty tissue with different shut-off elements; and

4 shows a detail view of a portioning container after closure thereof.

1 shows a schematic embodiment of a sterile device 1 for removing and portioning fatty tissue.

About a per se known suction cannula 2, which has one or more meh ^¬ rere lateral openings, the subcutaneous fatty tissue is aspirated. For this purpose, is to a hose 3 between the suction cannula 2 and a collecting container 4 is a peristaltic pump 5, and peristaltic pump (not shown) which conveys the aspirated adipose tissue of the suction cannula 2 in the collecting container ^¬. 4 Before the sump 4, a shut-off device 7 may be arranged. The collecting container 4 is connected via a connecting element 6 and a shut-off device 7 with a liquid ^¬ keitsbehälter 8. In this liquid container 8, which is derived from the fatty tissue in the collecting container 4 by gravity sedimenting liquid is discharged until the collection container 4 Rei ^¬ nes fatty tissue. For portioning of adipose tissue are now via further connecting elements 6 and corresponding Absper ^¬ rorgane 7 plurality Portionierbehälter 9 is connected. After removal of the fatty tissue which is arranged on the tube 3

Peristaltic pump 5 (not shown) in its direction of rotation umgege- returns so that the fatty tissue from the collecting container 4 can be successively conveyed into the portioning container 9. Once the respective portioning container 9 has been filled with a sufficient amount of fatty tissue, the associated obturator 7 is closed ge ^¬ . Once the last Portionierbehälter was 9 filled with fatty tissue and the associated shutoff WUR closed 7 ^¬ de excess fat tissue can at best be transported in a container About ^¬ shot. 11 This too

Surplus container 11 is connected via a corresponding connection ^¬ element 6 and a shut-off device 7 with the collecting container 4.

The necessary components of the device 1 for the removal and portioning of fatty tissue, namely the suction cannula 2, the tube 3, the collecting container 4, the liquid container 8, the at least one portioning container 9, possibly the excess container 11 and the respective connecting elements 6 and shut-off elements 7 are fluid-tight connected to a sterile, closed system, and placed in a sterile package 10. As a result, fatty tissue can be removed and portioned under sterile conditions using the device 1, without the space in which the fatty tissue removal is undertaken being itself sterile or a clean room having to be used.

The number of Portionierbehälter 9 is adapted to the particular circumstances. For example, in the device 1, three to five, but also more, portioning container 9 may be provided. The connecting elements 6 are gebil ^¬ det in the simplest case by corresponding hose pieces 12 and connectors 13, as explained in more detail with reference to the detail drawing in Figure 3.

On the collecting container 4 and / or on the at least one portioning container 9, an addition and / or removal opening 18 may be arranged, taken over the fatty tissue, or certain substances may be added. This addition and / or removal opening 18, which is for example welded to the respective container, can be formed by a closable connection, for example a luer lock connector, or a piercing ^¬ membrane. In order to suspend the containers, corresponding suspension openings 19 are arranged on the collecting container 4 and / or on the liquid container 8 and / or on the at least one portioning container 9 and / or on the excess container 11.

For a corresponding assignment of the patient to the removed and portioned fatty tissue, corresponding labels 21 with corresponding information are arranged on the collecting container 4 and / or liquid container 8 and / or portioning container and / or excess container 11. The labels 21, in particular adhesive labels, may already be arranged on the containers, or prior to the removal of the fatty tissue on the

glued corresponding container.

The sterile packaging 10 of all components of the device 1 for removing and portioning the fatty tissue is ^{vorzugswei ¬} se tool-less apparently by a corresponding tear-open tab or tear notch is included.

Fig. 2 shows the device 1 for the removal and portioning of fatty tissue according to Fig. 1 in the application. After opening the sterile package 10, the components of the device 1 are attached to a corresponding holding device 20, and the peristaltic pump 5 is mounted. In a purely mechanical application, the shut-off devices 7 are operated manually after the suction of the fatty tissue and the separation of the liquid content in the fatty tissue in the container 4 in the Flüssigkeitsikeitsbehälter 8 and finally after reversal of the hose pump, the portioning of the fat tissue in the portioning 9 and possibly in the excess container 11th performed. After filling the Portionierbehälter 9 with fatty tissue and after closing the Portionierbehältern 9 associated shut-off valves 7, the Portionierbehälter 9 are sealed fluid-tight and further recovery, such as cooling or stem cell production, fed.

In an automated or partially automated application for example, solenoid valves may be used as shut-off devices 7 ^¬ to which as well as the peristaltic pump 5 corresponding with a Control device 16 are connected. The control device 16 actuates the peristaltic pump 5 and the corresponding Ab ^¬ locking members 7 according to a predetermined time pattern, so that the removal and portioning of the fatty tissue can be supported. An operating unit, for example a computer, can be connected to the control device 16.

FIG. 3 shows a detailed view of two portioning containers 9 of the apparatus 1 for removing and portioning fatty tissue. The portioning container 9 are preferably formed by fle ^¬ xible plastic bag 17 and corresponding

Connection elements 6 to the reservoir 4 (not Darge ^¬ asserted) connected. The connecting elements 6 can by

Hose pieces 12 and connectors 13, for example T-pieces or Y-pieces, be formed, which are fluid-tightly connected to each other and preferably glued or welded who ^¬ . The shut-off devices 7 can be operated by manually

Hose clamps 14 or automatically actuated solenoid valves 15 may be formed.

Finally Fig. 4 shows a detailed view on a portio ^¬ nierbehälter 9 thereof according to closure. After filling the Portionierbehälters 9 with the fatty tissue, the associated obturator 7 is actuated and then the Portionierbehälter 9 sealed fluid-tight, for example by the arrangement ei ^¬ ner weld 22 on the connected to the Portionierbehälter 9 piece of hose. Thereafter, the piece of tubing can be separated below the weld 22 and the filled and ^{verschlos ¬} sene Portionierbehälter 9 further recovery, for example, stem cell production or cooling, are supplied.

The described device 1 for the removal and portioning of fatty tissue is characterized by particular simplicity and cost-effective manufacturability and allows Portionie ^¬ tion of fatty tissue for the further utilization thereof, in particular for the production of adult stem cells from the

Fatty tissue.

Claims

Claims:

1. Device (1) for the removal and portioning of fatty tissue, with a suction cannula (2) and thus one over

Hose (3) connected collecting container (4), to which hose (3) a peristaltic pump (5) can be arranged, characterized in that the collecting container (4) via a connecting element (6) with a shut-off device (7) with a liquid container (8 ) is connected to receive a fat from the fatty tissue in the collecting container (4) by gravity settling liquid, and that the collecting container (4) via further connecting elements (6) with at least one Portionierbehälter (9), wherein the suction cannula (2), the hose (3), the collecting container (4), the liquid container (8), the at least one Portionierbehälter (9) and the connecting elements (6) fluid-tight mitein ^¬ other connected to a sterile closed system and in a sterile packaging (10) are arranged.

2. Device (1) according to claim 1, characterized in that a plurality, preferably three to five, Portionierbehälter (9) are provided.

3. Device (1) according to claim 1 or 2, characterized in that the collecting container (4) via a connecting element (6) with a shut-off device (7) with an excess container (11) is connected.

4. Device (1) according to one of claims 1 to 3, characterized in that at least one connecting element (6) by at least one hose piece (12) and at least one connecting ^¬ piece (13) is formed, which at least one piece of hose (12) and which at least one connecting piece (13) is connected to one another in a fluid-tight manner, preferably glued or welded.

5. Device (1) according to one of claims 1 to 4, characterized in that at least one obturator (7) by a hose clamp (14) is formed.

6. Device (1) according to one of claims 1 to 5, characterized indicates that at least one shut-off device (7) through a measure ^¬ gnetventil (15) is formed.

7. Device (1) according to claim 6, characterized in that each solenoid valve (15) with a control device (16) is connected, which control device (16) with the

Peristaltic pump (5) is connectable.

8. Device (1) according to one of claims 1 to 7, characterized in that the collecting container (4) and or or the liquid container (8) and or or at least one portioning container (9) and or or the excess container ( 11) is formed by flexible plastic bag (17).

9. Device (1) according to one of claims 1 to 8, characterized in that the collecting container (4) and or or at least one portioning container (9) at least one addition and / or removal opening (18) is arranged.

10. Device (1) according to claim 9, characterized in that the addition and / or removal opening (18) is formed by a closable connection.

11. Device (1) according to claim 9 or 10, characterized in that the addition and / or removal opening (18) is formed by a piercing membrane.

12. Device (1) according to one of claims 1 to 11, characterized in that the collecting container (4) and or or on the liquid container (8) and or or at least one portioning container (9) and or or on the excess container (11) at least one suspension opening (19) is arranged.

13. Device (1) according to one of claims 1 to 12, characterized in that a holding device (20) for releasably securing at least the collecting container (4) and or or the liquid container (8) and or or the at least one Por ^¬ tioning container (9) and or or the excess container (11) is provided.

14. Device (1) according to claim 13, characterized in that the holding device (20) for fastening the collecting container (4) above the liquid container (8) is formed.

15. Device (1) according to one of claims 1 to 14, characterized in that the collecting container (4) has a capacity of 500ml to 2000ml.

16. Device (1) according to one of claims 1 to 15, characterized in that the at least one portioning container (9) has a capacity of 10ml to 200ml.

17. Device (1) according to any one of claims 1 to 16, characterized in that the collecting container (4) and or or liq ^¬ sigkeitsbehälter (8) and or or at least on a Portionierbehälter (9) and or or excess container ( 11)

Label (21) is arranged.

18. Device (1) according to one of claims 1 to 17, characterized in that the sterile packaging (10) without tools of ^¬ fenbar is formed.