|Número de publicación||WO1999033501 A1|
|Tipo de publicación||Solicitud|
|Número de solicitud||PCT/IL1998/000619|
|Fecha de publicación||8 Jul 1999|
|Fecha de presentación||21 Dic 1998|
|Fecha de prioridad||29 Dic 1997|
|Número de publicación||PCT/1998/619, PCT/IL/1998/000619, PCT/IL/1998/00619, PCT/IL/98/000619, PCT/IL/98/00619, PCT/IL1998/000619, PCT/IL1998/00619, PCT/IL1998000619, PCT/IL199800619, PCT/IL98/000619, PCT/IL98/00619, PCT/IL98000619, PCT/IL9800619, WO 1999/033501 A1, WO 1999033501 A1, WO 1999033501A1, WO 9933501 A1, WO 9933501A1, WO-A1-1999033501, WO-A1-9933501, WO1999/033501A1, WO1999033501 A1, WO1999033501A1, WO9933501 A1, WO9933501A1|
|Inventores||Igal Sharon, Michael Inbar|
|Solicitante||T.C.T. Products Ltd.|
|Exportar cita||BiBTeX, EndNote, RefMan|
|Citas de patentes (10), Citada por (65), Clasificaciones (3), Eventos legales (8)|
|Enlaces externos: Patentscope, Espacenet|
SUCTION-BASED TISSUE COLLECTING DEVICE
FIELD OF THE INVENTION
The present invention relates to a suction drainage device for use in vacuum aspiration procedure in which tissue or body fluids are removed from the body. Particularly, the invention relates to such a device for use in a variety of medical procedures where body fluid and tissue are sucked together and where it is desired to separate between the tissue and the fluid, e.g. for subsequent pathological examination of the collected tissue or cytological assay of cells in the fluid. A particular example for use of such a system is in dilatation and curettage (D&C procedure).
BACKGROUND OF THE INVENTION
In various medical procedures a tissue or body fluid is removed from the body by vacuum aspiration. A specific example is a D&C procedure where the lining of the uterus is scraped to remove embryonic tissue in order to terminate an undesired pregnancy, to remove tumorous and pre-tumorous tissue, etc. It is usually desired to subject the tissue collected in such a procedure to a pathological examination, e.g. to determine the existence of a cancerous or a pre-cancerous state. As tissue is typically sucked together with body fluids including blood, mucous, etc., in order to examine the tissue, it has to be separated from the fluid. Furthermore, it is at times desired to perform a cytological examination on cells in the sucked body fluids. Another problem of such aspiration procedures is that the collected biological material may often be highly infectious and there is a need to protect medical personnel from direct contact with this potentially hazardous material. Also the material which is used to treat the tissue or cells for fixation or preservation (all such material to be referred to herein as "treatment material ") may also be hazardous and direct contact therewith should also be avoided.
U.S. Patents 5,185,007, 5,234,419 and 5,589,145. disclose a suction drainage device that reduces the exposure of the medical personnel to potentially infectious waste material. The device has a collecting chamber which is associated with a reservoir containing waste treatment material, which can be opened by the user to allow release of the waste treatment material into the chamber. U.S. Patent No. 5,549,585, discloses a suction drainage device with a receptacle which cooperates with an external container, holding a waste treatment material, e.g. a gelling agent, which once fitted with the receptacle can release the waste treatment material therein. U.S. Patent No. 5,757,293 discloses a suction drainage system where the inlet suction tube is fitted with a tissue collector, typically a nylon mesh, for collecting the tissue bits. The tissue collector with the collected tissue bits can then be removed for tissue staging for pathological examination.
GENERAL DESCRIPTION OF THE INVENTION
It is an object of the invention to provide a device for use in vacuum aspiration procedures (a suction drainage device) which provides a new solution to both the medical personnel performing the aspiration procedure as well as to the medical personnel performing a subsequent examination of the collected biological material (tissue bits, body fluids, cellular material in the body fluids, etc.).
It is particularly an object of the invention to provide a suction drainage device which protects the medical personnel from direct contact with the aspirated biological material during the procedure and at the same time allows easy separation between collected tissue bits and fluid.
It is another object of the invention to provide a suction drainage device which protects the medical personnel from direct contact with the potentially hazardous treatment material.
It is an object of the invention to provide a novel, typically designed single use suction drainage device for collecting tissue bits, separating between them and the fluid, and treating the collected tissue bits with a treatment material, without any substantial risk of contamination of the personnel by either the collected tissue or fluid, or the treatment material.
It is an object according to one preferred embodiment, to provide a system for the separation and separate containment of aspirated tissue bits on the one hand and body fluids and cellular material suspended therein on the other hand for subsequent separate examination. The present invention provides a device and system, simple and convenient for use, which provides an overall solution for aspirating, collecting and subsequent examining of tissue bits, body fluids and cellular material contained in the body fluids, without exposure of the medical personnel to either the collected material or to the treatment material. The device in accordance with the invention is particularly useful as a disposable, single-use device, although in some embodiments, the device may also be made to be reusable.
The present invention provides a suction drainage device comprising a tissue collecting container with an inlet port for connecting to an inlet tube line leading from the source to be drained, and a vacuum port for connecting to a vacuum source; the device being characterized by: an inlet duct which extends within the container from the inlet port and terminating at an end fitted with a tissue trap for retaining tissue bits and allowing fluid passage therethrough; a vacuum duct which extends within the container from the bottom wall of the container to the vacuum port; and a sealed reservoir integral within the container and containing a liquid tissue-treatment material and provided with an external actuator for dispensing of the liquid tissue treatment material into the container so as to flood the tissue bits with said liquid.
The vacuum duct in the device of the invention allows to drain liquids out of the container. At times it is also desired to retain collected liquids within the container, e.g. in case the drainage system does not have a separate liquid trap. Thus, by one embodiment, the container comprises a second vacuum port, devoid of vacuum duct; the user can then connect the vacuum tube to either one of the two vacuum ports, depending on the system's set up. In addition, a device in accordance with this embodiment having two vacuum ports, one provided with the vacuum duct and the other without, can serve as a standard design for a device in a system comprising two such devices, where one for collection of tissue bits and the other serving as a liquid trap (in this connection see also below). For ease of description, a device of the invention according to this embodiment having two vacuum ports, will be referred to herein as the "two vacuum port device "). The second vacuum port, that devoid of a vacuum duct, may typically be fitted with a unit designed to prevent withdrawal of liquid out through the vacuum port. Such unit may, for example, be a float valve as known er se. In addition, the second vacuum port may also be provided with a biological filter, which is also known er se. The device of the invention may be used in a variety of vacuum aspiration procedures, a particular example being the DNC procedure materially used to terminate undesired pregnancy primarily in the first trimester of pregnancy.
The device of the invention is typically a disposable device, designed for a single use. The device may be provided together in a ready-to-use configuration or may provide a collection of components for assembling the device. In addition, the device may also at times be provided with a probe for tissue of fluid collection (or both) already connected to the inlet port. The tissue trap may be rigid or flexible, slotted and/or perforated, and constructed of metallic, synthetic, cloth, and other types of materials, depending on the requirements and the preference of a particular user. An important requirement of the structure and construction of the trap is that it allows, on the one hand, liquid drainage therethrough, and on the other hand, has pores of a mesh size such that tissue bits are retained within it. In accordance with one embodiment, the trap is a small container with one or more walls which are either perforated or fitted with a sieve. According to another embodiment, the trap is a flexible or pliable net. typically made of a nylon mesh. The vacuum duct which extends to the bottom has an opening which is designed in a manner allowing an almost complete removal of all fluids drained through the tissue trap.
The reservoir may have various designs permitting it to be sealed in a storage state, while allowing opening and dispensing of the treatment material into the container when in use. By one embodiment, the reservoir has an opening fitted with a closure member which can be displaced from a storage to a dispensing position to open the opening once actuated by the user. By another embodiment, the opening of the reservoir it fitted with a tearable or pierceable wall portion, e.g. a film which is ruptured upon user actuation. The amount of liquid treatment material contained within the reservoir should preferably be sufficient so once dispensed into the container it at least floods all the tissue bits contained in the tissue trap. Typically, the tissue trap will be at the bottom of the container so as to minimize the amount of liquid treatment material required to flood the tissue bits. In accordance with an embodiment of the invention, the tissue collection device is connected in a series to a liquid trap for collecting liquid drained from the container. The liquid trap may be a device ("the second device ") similar to the tissue collection device ( "the first device "), having an inlet port and a vacuum port, with the inlet port being connected to the vacuum port of the first device and its outlet port being connected to a vacuum source. In distinction to the first device, in the second device there is no duct extending from the vacuum port to the bottom wall of the container, whereby fluid, which enters the second device is collected at its bottom. In accordance with a preferred embodiment, the second device also comprises an integral reservoir which may have the same or a different design than the reservoir of the first device, and which also contains a treatment material, for treating the collected liquid.
By one embodiment of the invention, both the first device and the second device are a standard two vacuum port device, with a different vacuum port being used in each of the devices, while the other port being sealed. Notwithstanding their potential identity in design, the reservoirs in the two devices may contain different treatment material, for example, a fixative for fixing the collected tissue bits in the first device and a preservation medium for maintaining the chemical integrity of the collected fluids or preserving cellular material in the collected fluid in the second device.
The treatment material in the reservoir of the first or the second container may be selected based on need, and may be any one or such materials known per se. In accordance with one embodiment, the treatment material in the reservoir of the first container is a fixative to fix the tissue for subsequent staging for pathological examination. In accordance with another embodiment, the treatment material in the reservoir of the second container is a preservation medium to preserve the cellular material contained in the collected liquid.
In order to allow subsequent examination of collected biological material (tissue bits in the first container and body fluid or cellular material suspended therein in the second container) the container should be fitted with an arrangement to either access the collected material or to remove it from the container. Such a closure may for example be a lid sealing the container during use and transportation but which can be opened to assess the collected biological material. In addition, the container, rather than having a lid, may be provided with a small opening, fitted with a closure which can be removed to allow access to the collected material or their removal. By one specific example, the vacuum port with its associated duct is formed within such a closure, which once opened can be removed with the trap containing the tissue bits, connected thereto. A device of the invention may also be provided with an integral aspiration system to aspirate the collected fluid system from within the container.
The invention will now be illustrated in some non-limiting specific embodiments, shown in the annexed drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is an isometric view of a suction drainage device according to an embodiment of the invention, with walls made transparent to show internal elements. Fig. 2 shows a system with two devices connected in series, with one being a tissue collection device, and another serving as a liquid trap. Fig. 3 shows the system of Fig. 2 during suction. Fig. 4 shows the system of Fig. 2 after ceasing the suction operating and releasing the treated material into each of the containers. Fig. 5 shows a device in accordance with another embodiment of the invention.
Fig. 6 shows the device of Fig. 1. after treatment with a treatment material, at a draining stage for draining of the tissue trap prior to removal thereof for pathological examination. DESCRIPTION OF SPECIFIC EMBODIMENTS
Reference is first being made to Fig. 1 showing a device 20, for use in a suction drainage system for the collection of tissue bits. The device has container 21 with a generally cylindrical shape, having a bottom wall 22. As will be appreciated, the container may have a variety of other shapes and a cylindrical shape is a mere non-limiting example. The walls of the container shown herein are transparent, although this is a mere example and one can appreciate that this need not necessarily be so. The container is typically made of a plastic material, although it may be made of any other suitable material, such as glass, metal, etc. The container is perfectly made to be disposable, intended for a single use.
The device 20 has a lid 23, which in the specific example is screw-fitted in a sealing manner, at a top opening of the container. The sealing may obviously be by a variety of other means known per se, particularly where the container is not cylindrical. The container of this embodiment is provided with an additional opening 24, defined by upright cylindrical wall 25, sealed in a bionet-type fitting by plug member 26. Defined within plug member 26 is an inlet port 27, having a ribbed end for a fluid tight connection with a flexible inlet tube line (not shown), as know per se. Defined in lid 23 is a vacuum port 28, for connection to a vacuum source (not shown). Each of ports 27 and 28 is associated with a respective cover, 30 and 32 for sealing these ports.
Extending downward from inlet port 27 is an inlet duct 34, provided with a hook member 35 and fitted at its lower end, with a trap 36, for trapping tissue bits. The trap may be made of a wide variety of material, such as nylon mesh, with pore sizes, typically not exceeding μm. Trap 36 attached to the end of duct 34, e.g. by means of spring ring 38, or by any other suitable means.
As will be appreciated, and as will also be illustrated with respect to the embodiments of Figs. 5 and 6, once plug member 26 is opened and removed, it removes with it duct 34 with its attached trap 36. Hook member 35 may then be hung on to cylindrical wall 25 to allow drainage of trap 36.
Extending downward from vacuum port 28, is a vacuum duct 40, terminating, at a bottom wall 22, in a drainage opening 42, situated at the end of a short horizontal section of duct 40.
The device 20 further has a reservoir 50. depending downward into the container from lid 24. The reservoir 50 has a pierceable closure film 52, fitted on an opening of bottom wall 54. Situated inside the reservoir 50, is a pointed spike 56, vertically displaceable by user manipulation, which in this specific embodiment is achieved by clockwise turning of manipulating knob 58; as a result of such displacement, the spike pierces film 52, allowing dispensing of the content of the reservoir into the container.
The reservoir 50, which, for reasons of illustration, is seen with transparent walls (which may either be transparent or not transparent), contains a liquid treatment material 62, typically a tissue fixative. A specific example of a fixative is formaldehyde.
The amount of treatment material 62 contained within reservoir 50, is such so that once released into the container, as represented by arrows 64, it floods the bottom of the container, such as to entirely cover trap 36, as will be illustrated also further below (see Fig. 3).
The vertical displacement of spike 56 is the result of a hellical displacement of manipulating knob 58. In order to avoid accidental displacement prior to use, knob 58 is provided with a tempering proof cap 66.
Fig. 2 shows a suction drainage system, comprising two devices: a first device 20, identical to that shown in Fig. 1, and a second device 80. Device 80 is similar by many of its components to device 20, and like components are given like numbers with a prime indication. The two containers are connected by a tube 81 leading from port 28 of device 20 to port 27 of device 80. Port 27 of device 80 is seen connected to an inlet tube 82 and port 28 of device 80 is connected to a vacuum tube 83. One important difference between device 80 and device 20 is that device 80 does not have a vacuum duct, such as duct 40 of the first device 20. Furthermore, in the shown embodiment, the inlet port 27' is not fitted with inlet duct, such as duct 34 of the first device 20. While first device 20 collects tissue bits, device 80 collects the body fluids and thus serves as a liquid trap. If desired, an inlet duct with a tissue trap may also be provided at inlet port 27' so as to collect residual tissue bits which escape trap 36 of device 20. Such an additional trap within device 80 may have a finer mesh size than that of trap 36. The structure and construction of such an additional trapping arrangement may be the same or different to that of trap 36 of device 20, and although not illustrated, it is no doubt clearly understood to the artisan. Outlet port 28 of device 80 is fitted with biological filter 84, and a one-way valve 85, e.g. a flood valve, both known er se.
Reservoir 50' of second device 80, typically contains a treatment material different than that contained in reservoir 50 of the first device 20: that contained in reservoir 50' is typically a preservation medium for preserving cellular material contained in the liquid trapped in device 80.
Reference is now being made to Figs. 3 and 4, showing the system of Fig. 2 in two operational states. In the state shown in Fig. 3, vacuum is applied at tube 83, and, consequently, tissue bits and fluid collected by a probe (not shown) fitted at the end of inlet tube 82 are drawn through tube 83. The liquid and the tissue bits then enter the container through duct 34 into tissue trap 36, wherein tissue bits 90 are entrapped while the drawn liquid 92 passes through trap 36. This liquid 92 is sucked through opening 42 of duct 40, then through tube 81 towards port 27', into container 80. where the collected liquid forms a pool 94.
After the suction operation is completed, the vacuum may be turned off. This is the state shown in Fig. 4. Preferably, tubes 81, 82 and 83 are then removed, and the port may then be fitted with caps 30 and 32 of the first device 20, and the corresponding caps 30 and 32 , of container 80. With such caps in place, the container may be transported or handled as will be explained below.
Reservoir 50 contains a liquid treatment material 64. which may, for example be formaldehyde, as already pointed out above. After the suction operation is complete, caps 66 and 66 can be removed and then knobs 58 and 58 may be actuated by clockwise turning, which causes advancement of spike 56 to rupture film 52 (see Fig. 1). Liquid treatment material 66 then flows into container 21 and fills the bottom up to level 100. The amount of liquid 66 should preferably be sufficient so that level 100 will be such so as to flood all tissue bits.
Reservoir 50 may contain treatment material in the form of a liquid or with particulate solid, e.g. a powder or lyophilisate (a particular solid, once dispensed, comes into contact with the liquid 94 collected in container 80, and dissolves therein.) For removal of collected tissue, lid 23 may be opened.
Alternatively ,. as already pointed out above, plug 26 is opened and removed pulling with it duct 34 with the attached trap 36 (See Fig. 6 and the description below). Similarly, the corresponding plug 26' in device 80 may be removed to open opening 24' out of which samples of the treated liquid 94 may be withdrawn. The device 80 may also be provided with aspiration duct, e.g. a duct similar to duce 40 of device 20 to allow withdrawal of liquid from device 80 by aspiration.
In accordance with an embodiment of the invention, container 20 and container 80 may be combined into one unit, permanently or detachably fixed to one another.
Reference is now being made to Figs. 5 and 6 showing device 100 in accordance with another embodiment. The device 100 is similar to device 20 shown in Fig. 1 and accordingly like elements have beginning like numbers. The difference between device 100 to device 20 is in that rather than having a lid 23, container 21' has an integral top wall 102. Furthermore, rather than having a single vacuum port 28. the device is fitted with an auxiliary vacuum port 104, provided with a lid 106. which may be fitted with a biological filter and a one-way valve, similar to components 84 and 85, respectively of device 80 shown in Fig. 2. This device can serve as a standard design in a two-device system, one for collecting of tissue bits and the other for collecting of liquids, such as the system shown in Fig. 2. In such a two-device system, port 28 will be utilized in the first device, with port 104 being sealed, while in the second device, port 104 will be used with port 28 being sealed (port 28 may serve for liquid withdrawal as explained above). Fig. 6 illustrates the step of removal of the collected tissue bits.
Plug 26 is opened and detached from opening 24, and withdrawn together with duct 34 which is integral therewith. Prior to complete withdrawal, hook 35 is hung on to cylindrical wall 25, to allow drainage of remaining liquid from trap 36. and after complete drainage, the trap may be removed for staging of the tissue bits.
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