Tissue collection bag

Abstract

The invention relates to a tissue collection bag (1) for a morcellation system, comprising two outer layers (2, 3) of a flexible sheet-like structure made of a liquid-impermeable material enclosing an inner volume and connected to one another at their edges, an inlet connection (4) for supplying liquid carrying tissue particles, an outlet connection (5) for discharging the liquid, and a filter device for retaining the tissue particles in the inner volume. The invention proposes a three-layer structure of the tissue collection bag (1), in which at least one intermediate layer (6) of a flexible sheet-like structure made of liquid-permeable and tissue-particle-impermeable material, located between the two outer layers (2, 3), forms the filter device and divides the inner volume into at least two chambers (7, 8), wherein the inlet connection (4) opens into one chamber (7) and the outlet connection (5) opens into the other chamber (8).The invention also relates to a hose system for a peristaltic pump (20), comprising a peristaltic hose (15) and a support, wherein the support is designed as a frame (16) with holding elements (17, 18) which hold the peristaltic hose (15) in an arcuate course on the frame (16), and a peristaltic pump (20) designed to receive the support of the hose system.

Description

The invention relates to a tissue collection bag for a morcellation system, comprising two outer layers of a flexible sheet of liquid-impermeable materials enclosing an inner volume and connected to one another at their edges, an inlet connection for supplying liquid carrying tissue particles, an outlet connection for discharging the liquid, and a filter device for retaining the tissue particles in the inner volume.Morcellation is understood to mean a surgical method for tissue comminution and removal during endoscopic procedures. The method is used, inter alia, in laparoscopic hysterectomy and in prostate nucleation. The corresponding instrument is called morcellator. The morcellator carries at its tip a moving knife which crushes the tissue such that it can be suctioned out of the surgical field in the form of tissue particles in a rinsing liquid. Apart from the morcellator, the morcellation system also includes a suction system with a suction pump and a tissue collection device. The latter retains the fabric particles carried by the aspirated liquid by suitable filter means. The tissue particles (the morcellate) thus collected are usually subjected to pathological examination.Known suction systems used in morcellation use a vacuum pump in connection with a vacuum container and a collecting container, which are connected to each other and to the morcellator via hoses. The liquid with the tissue particles sucked in at the morcellator flows through the collecting container. The fabric particles are retained there and the liquid flows away in the direction of the vacuum container. After surgery, the vacuum system is vented and the collection container with tissue removed. A filter device (e.g. a grid basket or a filter bag) can be located in the collecting container. To prevent the reservoir from collapsing under vacuum and obstructing the fluid path, a rigid design is required. The volume of the container must therefore correspond at least to the required capacity for tissue particles.The described prior art system has a complicated structure. Its use is therefore complicated, susceptible to breakdown and also expensive. A plurality of hose connections must be re-established manually at each OP and after each interrupt of an OP. The collecting container must be opened, cleaned and closed again; suitable filter devices must be kept in stock.AU 2020 204 0909 A1 describes a system for tissue extraction and retrieval which comprises a primary chamber which is connected to a secondary chamber. Between the first and the second chamber there is a separating device which enables a controlled transfer of the removed tissue and at the same time ensures a secure separation. The separating device can be designed in the form of a valve or a flexible membrane. The system improves the safety of tissue extraction, minimizes the risk of contamination and facilitates handling of the extracted material. The device can comprise various structural designs which enable optimum adaptation to specific medical applications.WO 2015 164 591 A1 discloses a system and a method for improved removal and processing of biological samples, in particular tissue or liquids, for diagnostic or therapeutic purposes. The system comprises a special device for sampling, which enables precise control of the removal and thereby minimizes contamination. The apparatus may be equipped with a filter system or separation unit to selectively retain or selectively pass certain components of the sample. Safe handling of the removed material is ensured, in particular with regard to later analysis or further medical processing.Also known is the product "MetraAg" from the manufacturer BOWA Medical, which is provided for controlled tissue morcellation in a closed system. The MetraAg system is a closed morcellation bag used during surgery to minimize the risk of tissue distribution in the abdomen. The system has been developed to ensure high safety, particularly to prevent inadvertent scattering of tissue debris.DE 10 2022 201 057 A1 describes a tissue collection bag of the type specified at the beginning, in which the filter device is formed by a liquid-permeable inner bag which is located in a liquid-impermeable outer bag. The tissue particles are retained in the inner bag. The combination of inner bag and outer bag, both of which are made of flexible, flexible material, is advantageous because larger amounts of tissue can also be accommodated therein. The tissue collection bag may be inserted downstream of a suction pump. There is then no vacuum on the tissue collection bag, so that there is no need for a rigid design. The tissue collection bag is a disposable product as a whole. Handling is significantly simpler, less susceptible to breakdown and more cost-effective than the systems described above.The known tissue collection bag, however, still has disadvantages: the construction with inner and outer bags is comparatively complicated and expensive to produce. In the previously known embodiment, the inner bag is freely movable in the outer bag. Accordingly, it can unintentionally roll in, knot or fold. Then, only a fraction of the surface of the inner bag is available as a filter surface and only a corresponding fraction of the volume is available for receiving the tissue particles. The tissue collection bag may then clog even if its tissue particle holding capacity is not yet exhausted in a batch manner.Against this background, it is an object of the invention to specify a tissue collection bag for a morcellation system which is improved in comparison with the prior art.This object is achieved by the invention, starting from a tissue collection bag of the type specified at the beginning, by a three-layer construction in which at least one intermediate layer lying between the two outer layers of a flexible sheet-like structure of liquid-permeable material impermeable to the tissue particles forms the filter device and divides the inner volume into at least two chambers, wherein the inlet connection opens into one chamber and the outlet connection opens into the other chamber.In contrast to the tissue collection bag known from the cited DE 10 2022 201 057 A1, the tissue collection bag of the invention does not have an inner bag as a filter device, but instead at least one layer of a flexible sheet material made of liquid-permeable material impermeable to the tissue particles. Thus, the tissue collection bag according to the invention can be manufactured very easily as an at least three-layer structure. For example, the three layers can each consist of a suitable plastic material (polymer film or polymer fabric material) which are cut to size, placed one above the other and connected to one another, preferably at their outer, circumferential edges, in particular welded or sealed to one another. An embodiment with two or more intermediate layers is also conceivable, which are e.g. net-like flat structures as filter devices, which differ from one another with regard to the mesh width. In this way, three or more chambers are formed accordingly, with the possibility of classifying the retained tissue particles according to size.The intermediate layer connected to the outer layers ensures that the entire surface of the intermediate layer is always available as a filter surface. The intermediate layer is not freely movable in the inner volume of the tissue collection bag independently of the outer layers, which reduces the susceptibility to faults and further simplifies handling.Through the inlet connection, the liquid carrying tissue particles reaches that of the two chambers, separated from one another by the intermediate layer, in the inner volume of the tissue collection bag according to the invention, into which the inlet connection opens. For this purpose, the input connection is expediently connected to the pressure side of a suitable suction pump. The intermediate layer allows the liquid entering the tissue collection bag via the inlet connection to pass and retains the tissue particles, which are correspondingly accommodated in the chamber. The liquid freed from the tissue particles reaches the other chamber and leaves the tissue collection bag from there through the outlet connection. The liquid can drain, for example, through a hose connected to the output connection.After the surgical procedure has been completed, it is often necessary to weigh the morcellate which has been obtained, for example to determine whether the tissue has been completely removed. For this purpose, the tissue collection bag according to the invention with the tissue collected therein can be weighed easily after the liquid has drained off. The net weight of the removed tissue is then obtained from the gross measured weight after subtraction of the (known) weight of the tissue collection bag.In one possible embodiment, the two outer layers are connected, in particular sealed or welded, to one another at their edges, as already explained above. The at least one intermediate layer can be connected at its edges to at least one of the two outer layers. Advantageously, at least some edges of the intermediate layer coincide with those of the outer layers, so that the connection can take place in a single operation in each case. The outer layers are expediently at least sufficiently dimensionally stable in this case that they hold the intermediate layer so to speak "clamped", i.e. fully unfolded. This ensures optimum filtering action.The intermediate layer can be connected at at least one of its edges to the corresponding outer layer in a region outside at least one of the edges of this outer layer. This makes it possible to arrange the output connection at the corresponding outer layer in a deep-lying region which is located in particular completely below the chamber accommodating the tissue particles. In this way, it is ensured that the liquid can drain completely freely out of this chamber. It is advantageous if the tissue collection bag tapers in a funnel-like manner in the region below the chamber accommodating the tissue particles downwards towards the outlet connection.The input terminal may be disposed at one of the outer layers at a position above the output terminal. This allows the liquid to pass through the tissue collection bag assisted by gravity. After switching off the suction pump, ventilating the tube system and disconnecting the tube system from the suction pump, liquid remaining in the tissue collection bag can drain freely through the outlet connection. Advantageously, the inlet and outlet connections are arranged on the same outer layer and are thus accessible from the same side of the tissue collection bag. This simplifies handling.In a further possible embodiment, the tissue collection bag has a holding device on at least one of its edges, in particular in the form of a hook or an eyelet. The holding device enables the tissue collection bag to be suspended. It is conceivable that the tissue collection bag is to be fastened to a holder provided for this purpose on the suction pump.At least a partial surface of the intermediate layer can have openings which are permeable to the liquid and impermeable to the tissue particles. The size of the openings can be, for example, 0.5-2 mm. In this case, the at least one partial surface of the intermediate layer can be formed by a mesh or a grid film. The intermediate layer can also consist entirely of such a material.In one possible embodiment, the inlet and / or the outlet connection can be reversibly closed in a fluid-tight manner by means of a closure element. A screw closure or a plug, for example, can serve as a reversible closure, which is sealingly screwed or plugged onto a threaded section or conical section of the inlet or outlet connection. Thus, the tissue collection bag can be easily sealed after completion of an surgical procedure and the collected tissue particles can be directly transferred for pathological examination without the need to use other containers in the tissue collection bag. For performing an operating procedure, the inlet and / or the outlet connection can each be easily connected to the suction pump or a collecting container for the draining liquid by means of connecting adapters with a suitable hose.An advantageous embodiment provides that at least one of the outer layers of the tissue collection bag has a rigidity which is sufficient for the tissue collection bag to assume a deployed, flatly spread configuration without the action of external forces. It has been found that it is advantageous in practice if the tissue collection container does not have to be transferred into a deployed, flat spread configuration only during the preparation of the surgical device. The stiffness of one of the outer layers can be adjusted such that the tissue collection bag automatically holds itself in the desired application configuration. This facilitates handling and contributes to an efficient operation in an surgical operation. The rigidity can be achieved by a suitable material rigidity of at least one of the outer layers. Likewise, at least one of the outer layers can be equipped with suitable stiffening elements. The two-dimensionally spread configuration achieved by the rigidity ensures an optimum filtering action and thus the function of the tissue collection bag.According to a further possible embodiment, one of the outer layers has on the outside a downwardly open pocket which extends substantially over the entire width of the outer layer and is provided for receiving therein a holder which maintains the tissue collection bag upright and in a deployed, flatly spread configuration. The pocket with the holder accommodated therein (for example in the form of a bow) serves to transfer the tissue collection bag into the desired application configuration in a simple manner and to hold it therein. The two outer layers of the tissue collection bag and the bag are expediently formed from a single blank of the liquid-impermeable material, which are connected, in particular sealed, to one another at their edges after the blank has been folded over twice. Manufacturing costs can be advantageously reduced by manufacturing the outer layers and the pocket from a single blank of the liquid impermeable material. The intermediate layer can be arranged, for example, before the double folding over, at a region on the (later) inner side of the blank which forms one of the two outer layers.A further possible embodiment of the invention provides that the inlet connection is designed as a multiple connection, provided for the selective supply of the liquid carrying tissue particles or of another liquid, in particular a disinfecting, sterilizing or preserving liquid, or for the removal of tissue particles from the inner volume of the tissue collection bag. The multiple connection allows different fluids to be supplied simultaneously or sequentially to the tissue collection bag. This eliminates the need to change the connection depending on the liquid source, which further simplifies the surgical procedure.Exemplary embodiments of the invention are explained in more detail below with reference to the figures. The following are shown: FIG. 1a is a schematic top view of a tissue collection bag according to the invention, FIG. 1 b : a sectional side view of the tissue collection bag from FIG. 1 a; FIG. 2 a : Sectional side view of an embodiment of the tissue collection bag with pocket; FIG. 2 b : Schematic illustration of a blank for producing the tissue collection bag of FIG. 2 a;In the following description of the figures, the same reference numerals and the same terms are used for the same elements.FIGS. 1 aand 1 bschematically show a tissue collection bag according to the invention. This is denoted overall by the reference numeral 1. This is a tissue collection bag 1 for a morcellation system, having two outer layers 2, 3 of a flexible sheet material of a liquid-impermeable material, for example a transparent, flexible polymer film material, which outer layers enclose an inner volume and are connected to one another at their edges 9, 10. An input connection 4 serves for supplying liquid carrying tissue particles. An output connection 5 is provided for discharging the liquid.The tissue collection bag 1 shown has a three-layer structure in which an intermediate layer 6 of a flexible sheet material made of liquid-permeable material, for example a mesh, impermeable to the tissue particles is located between the two outer layers 2, 3 and forms a filter device for retaining the tissue particles in the inner volume of the tissue collection bag 1. As can be seen in particular in FIG. 1 b, the intermediate layer 6 divides the inner volume into two chambers, wherein the inlet connection 4 opens into the one chamber 7 and the outlet connection 5 opens into the other chamber 8.The liquid carrying tissue particles reaches the chamber 7 through the inlet connection 4; for this purpose, the inlet connection 4 is expediently connected to the pressure side of a suitable suction pump (not shown). The intermediate layer 6 allows the liquid to pass and retains the tissue particles which are correspondingly received in the chamber 7. The liquid passes through the intermediate layer 6 into the chamber 8 and leaves the tissue collection bag 1 from there through the outlet connection 5.As can be seen in FIG. 1 a, the two outer layers 2, 3 are sealed to one another at their circumferential edges 9. The upper and lateral edges of the intermediate layer 6 coincide with the edges 9 of the outer layers 2, 3 and are sealed there with these. The intermediate layer 6 is sealed at its lower edge 10 only with the outer layer 2 on the right in FIG. 1 b, namely in a region above the lower edge 9 of the outer layers 2, 3. The output connection 5 is arranged in the lowermost region of the tissue collection bag 1. This region is located completely below the chamber 7 receiving the tissue particles. On the upper edge 9, a holding device 11 for hanging the tissue collection bag 1 is provided, in particular in the form of a hook or an eyelet (not shown). The height of the tissue collection bag can be, for example, 21 cm, while the width is 15 cm.FIG. 2 ashows a schematic sectional representation of a configuration of the tissue collection bag 1 with pocket 12, the pocket 12 being arranged on the rear side on the outer layer 3 and being open downward. It extends substantially over the entire width of the outer layers 2, 3. For this purpose, as illustrated in FIG. 2 b, the pocket 12 and the outer layers 2, 3 are manufactured from a single blank 14 of a liquid-impermeable material. In the embodiment shown, the tissue collection bag 1 is obtained by folding and folding the blank 14 twice and sealing it at the edges 9 (see FIG. 1 a). The vertically extending edges are formed by the crease lines between the sections 2, 3, 12 of the blank 14, so that no sealing is required there. Previously, the intermediate layer 6 is applied to the central portion of the blank 14 by sealing along the edge 10. The pocket 12 is intended to receive a holder 13 therein to hold the tissue collection bag 1 upright in a deployed, spread-out configuration. The expediently bow-shaped or plate-shaped holder 13 extends in the pocket 12 preferably substantially over the entire width of the tissue collection bag 1, stiffens it as a result and holds it in the intended configuration.

Claims

Tissue collection bag (1) for a morcellation system, having two outer layers (2, 3) of a flexible sheet of a liquid-impermeable material enclosing an inner volume and connected to one another at their edges, an inlet connection (4) for supplying liquid carrying tissue particles, an outlet connection (5) for discharging the liquid, and a filter device for retaining the tissue particles in the inner volume, characterized bya three-layer structure, in which at least one intermediate layer (6) of a flexible sheet of liquid-permeable material impermeable to the tissue particles, which intermediate layer is situated between the two outer layers (2, 3), forms the filter device and divides the inner volume into at least two chambers (7, 8), wherein the inlet connection (4) opens into the one chamber (7) and the outlet connection (5) opens into the other chamber (8).Tissue collection bag (1) according to claim 1, wherein the two outer layers (2, 3) and the at least one intermediate layer (6) are connected, in particular sealed, to one another, wherein the intermediate layer (6) is connected at its edges (9, 10) to at least one of the outer layers (2, 3).Tissue collection bag (1) according to claim 2, wherein the at least one intermediate layer (6) is connected at at least one of its edges (10) to the outer layer (2) in a region outside at least one of the edges (9) of this outer layer (2).Tissue collection bag (1) according to one of claims 1 to 3, wherein the tissue collection bag (1) has a holding device (11) on at least one of its edges (10), in particular in the form of a hook or an eyelet.Tissue collection bag (1) according to one of claims 1 to 4, wherein at least a partial surface of the at least one intermediate layer (6) is formed by a mesh or a grid film.Tissue collection bag (1) according to one of claims 1 to 5, wherein the inlet and / or the outlet connection (4, 5) can be reversibly closed in a fluid-tight manner by means of a closure element.Tissue collection bag (1) according to one of claims 1 to 6, wherein at least one of the outer layers (3) has a rigidity which is sufficient for the tissue collection bag (1) to assume a deployed, two-dimensionally spread configuration without the action of external forces.The tissue collection bag (1) according to any one of claims 1 to 7, wherein one of the outer layers (2, 3) has on the outside a downwardly open pocket (12) extending substantially across the entire width of the outer layer (2, 3) provided to receive therein a holder (13) which maintains the tissue collection bag (1) upright and in a deployed, flat spread configuration.Tissue collection bag (1) according to claim 8, wherein the two outer layers (2, 3) and the bag (12) are formed from a single blank (14) of the liquid-impermeable material, which are connected, in particular sealed, to one another at their edges (9, 10) after the blank (14) has been folded over twice.Tissue collection bag (1) according to one of claims 1 to 9, wherein the inlet connection (4) is designed as a multiple connection, provided for the selective supply of the liquid carrying tissue particles or of another liquid, in particular a disinfecting, sterilizing or preserving liquid, or for the removal of tissue particles from the inner volume of the tissue collection bag (1).

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