Retrieval device and method for retrieving tissue

Abstract

According to the invention, in order to remove tissue, in particular pathogenic tissue, from a body cavity of a patient, a removal device is provided having a removal bag (12) which is completely or partially composed of a hydrophilic, water-permeable filter membrane (26). The filter membrane (26) comprises a pore width of preferably less than 12 pm, further preferably less than 8 pm and in a preferred case less than 5 pm, in order to reliably avoid the passage of pathogenic cells or other pathogenic material. However, the pores are at least large enough so that water can easily exit from the removal bag (12). In this way, the removal bag (12) only needs to be occupied by the volume of the contained tissue to be removed in the filled state. The liquid provided within the removal bag (12) can be drained from the removal bag through the filter membrane (26) and thus does not increase its volume. This allows relatively large tissue masses to be accommodated during tumor removal. Thus, tumors can be removed as a whole without having to separate them within the body cavity. As a result, the risk of malignant tissue spreading and the risk of recurrence associated therewith is significantly reduced.

Description

Technical Field

[0001] The present invention relates to a removal device for removing tissue from a human or animal patient, in particular from a body cavity filled with fluid, such as, for example, the bladder. Background Art

[0002] For example, DE 699 07 796 T2 discloses a device and an arrangement for removing infectious tissue released during surgical intervention on a patient. The device comprises an insertion tube through which extends an axially movable plunger tube. The plunger tube is connected at its distal end to an arcuate retaining rail, from which a bag is suspended. A yarn guided through the upper edge of the bag allows the bag to be closed.

[0003] Other removal devices with bags are known from WO 93 / 15671, US Pat. No. 6,350,267 B1, EP 2 353 511 A1, US Pat. No. 6,2289,095 B1, US Pat. No. 5,341,815, EP 2 605 709 A2, WO 2012 / 026809 A2, and EP 2 497 429 A1. The latter document discloses a removal bag provided with a gas outlet. For this purpose, a hydrophobic air filter material or such a membrane is provided. The hydrophobic filter material prevents liquid from passing through due to its water-repelling effect, but allows gas to escape.

[0004] During tissue removal in fluid-filled body cavities (e.g., the bladder), it can be important to completely contain the pathologically altered tissue (e.g., diseased tissue) as a large, non-dissociated mass as possible and to remove it from the body cavity without leaving behind individual tissue remnants or cells. Any retrieval bag must be dimensioned accordingly. Furthermore, such a retrieval bag must be removed from the patient through an access path (e.g., the working channel of an endoscope). Summary of the Invention

[0005] Based on this, the object of the present invention is to provide a removal device and a method for removing tissue, by means of which tissue can be reliably accommodated and by means of which tissue can be reliably removed from the patient's body via a working channel of an access instrument (such as an endoscope).

[0006] This object is achieved by means of the removal device according to the invention:

[0007] The retrieval device according to the present invention comprises a retrieval bag for removing cells from a fluid-filled cavity inside a patient's body. The fluid may be an endogenous fluid, such as urine, bile, pancreatic secretions, or cerebrospinal fluid, or it may be an externally supplied fluid, such as a sodium chloride solution. The retrieval bag comprises a filling opening and a bending-resistant or flexible traction device connected to the retrieval bag. Furthermore, the retrieval bag comprises a section consisting of a hydrophilic, water-permeable filter membrane. Such a filter membrane is any filter membrane whose pore width is small enough to reliably retain tissue remnants or cells of the removed tissue. Thus, the volume of the retrieval bag, when closed, can be reduced by squeezing out water to a volume that is not significantly larger than the volume of the removed tissue. Therefore, the retrieval device is particularly suitable for use in fluid-filled body cavities. This avoids the retrieval bag from having an unnecessarily large space requirement due to the amount of water absorbed. In this way, it is possible to place relatively large tissue sections as a whole in the retrieval bag and - after draining off excess fluid - still remove the retrieval bag from the patient through a relatively narrow working channel of an accessible instrument (eg an endoscope or cystoscope).

[0008] The retrieval device according to the present invention is particularly advantageous during use of a cystoscope, which typically includes only one working channel. By removing excess fluid from the retrieval bag and thus reducing its volume, the retrieval bag can hold larger tissue masses, allowing the tumor to be removed as a whole without having to separate them. This also eliminates the need for surgeons to make multiple changes between instruments and the retrieval device.

[0009] The filling opening of the retrieval bag can be provided with a closure device, which can be implemented, for example, by a profile-strip closure. The profile-strip closure can be used to close the retrieval bag in a fluid-tight manner. The profile-strip closure comprises two complementary strips that can be snapped together along their entire length and thereby provide a fluid-tight closure of the filling opening of the retrieval bag. To this end, the two strips of the profile-strip closure can be sealingly and non-releasably connected at the proximal and distal ends so that, in the closed state, liquid that may contain any cells cannot leak out.

[0010] The closure device includes an open position in which the retrieval bag is widely open and can accommodate tissue and liquid. Furthermore, the closure device includes a closed position in which the receiving opening of the retrieval bag is closed. Preferably, the closure device is biased toward its open position. The two strips of the profile strip closure are resiliently arched away from each other.

[0011] The retrieval bag may include two preferably flexible side walls that abut each other if the retrieval bag is closed. This is helpful during drainage of liquids, particularly water, from the retrieval bag. The flexibility of the side walls is preferably high enough that the retrieval bag can be coiled into a coil that fits through the working channel of an endoscope or cystoscope.

[0012] The retrieval bag may be equipped with a wringing device. The wringing device can be used to drain the liquid (especially water) contained in the retrieval bag from the retrieval bag after it has been closed. The hydrophilic filter membrane allows water and aqueous solutions to escape, while retaining cells and tissue components.

[0013] The retrieval bag can be made entirely of a hydrophilic, water-permeable filter material. However, the retrieval bag can also include at least one water-impermeable section, for example in the form of a plastic film, which forms one or both side walls of the retrieval bag. The plastic film can include windows at one or more locations, in or on which the hydrophilic, water-permeable filter membrane is attached.

[0014] The filter material is preferably a fleece, a woven fabric, a braided fabric, a knitted fabric or a porous membrane. Thus, the filter material can be selected from the group consisting of:

[0015] Polyethersulfone (PES), acrylic polymers, polyamide (PA) or polyethylene terephthalate, polysulfone (PS), polyethylene terephthalate hydrophilized polytetrafluoroethylene (PTFE), cellulose acetate (CA), cellulose nitrate (CN), cellulose acetate and cellulose nitrate (MCE), nylon (NY), polycarbonate (PCTE), polyvinylidene fluoride (PVDF), with or without a supporting material (e.g. polyester). Furthermore, the filter material can be composed of coated fibers or microperforated films, such as cellulose fibers, such as paper-like fleece of cellulose fibers, which can be coated with, for example, 2,2-dimethoxy-2-phenylacetophenone, 3-(1H,1H,2H,2H-perfluorooctyl)-1-vinylimidazolium iodide, 3,3'-(hexane)-1,6-diyl)bis(1-vinylimidazolium) dibromide, and impregnations of acetonitrile and propan-1-ol. The following materials have proven to be particularly suitable: polyethersulfone (PES), acrylic polymers, polyamide (PA) and polyethylene terephthalate.

[0016] The filter material preferably has a maximum pore size of less than 5 μm. Smaller upper pore sizes can be provided, such as 3 μm, 2 μm, 1.2 μm, 0.8 μm, 0.65 μm, 0.45 μm, or 0.2 μm. Although very small pore sizes can generally be used, it is also conceivable not to set the minimum pore size below 0.2 μm, thereby achieving a higher water permeability of the filter membrane while at the same time reliably retaining typical tumor cells.

[0017] Using the presently described removal device, the removal method of the present invention can be implemented as follows:

[0018] First, a retrieval bag is introduced into the body cavity, for example, through the working channel of an endoscope or cystoscope in a folded or coiled state and released there, so that the retrieval bag is ready to receive the cellular material. After the material to be removed is introduced into the retrieval bag, the retrieval bag is closed. The liquid enclosed in the retrieval bag is then removed from the retrieval bag through a filter membrane to reduce its volume. The retrieval bag, thus compressed in volume, can now be removed from the patient's body cavity again through the working channel of the endoscope or cystoscope or another access port. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Details and advantageous embodiments of the invention can be found in the individual figures of the accompanying drawings and the corresponding descriptions.

[0020] Figure 1 The distal end of a cystoscope is shown in perspective view, wherein a retrieval device with a retrieval bag is supported in the cystoscope,

[0021] Figure 2 Shown in perspective Figure 1 a retrieval bag which, in an open state, is ready to receive the cellular material,

[0022] Figure 3 A partial view of the upper edge of the removal bag is shown in a perspective sectional view to illustrate its closure device,

[0023] Figure 4 The vertical section shows the closed state Figure 3 The closure device,

[0024] Figure 5 shows a portion of the wall of a bag with a filter membrane,

[0025] Figure 6 An improved embodiment of the wall of the retrieval bag with a filter membrane is shown.

[0026] Figure 7 A removal device is shown with a wringing device for removing the bag. DETAILED DESCRIPTION

[0027] exist Figure 1, a retrieval device 11 and a retrieval bag 12 as part of the retrieval bag are shown inserted into a cystoscope 10. The retrieval device 11 can be inserted through a working channel 13 of the cystoscope 10 into a body cavity 14 of a patient, for example into the bladder or another body cavity, in which a surgical procedure, such as tumor resection or other tissue resection, is to be performed. The body cavity 14 is thus typically filled with a liquid, such as an endogenous liquid, for example urine, bile, pancreatic secretions, cerebrospinal fluid, or a supplied liquid, such as sodium chloride solution. The cystoscope 10 comprises only one working channel 13, through which different instruments can be inserted into the body cavity 14. Such instruments are shifted through the working channel 13 alternately with the retrieval device 11. The cystoscope 10 comprises an optical system 15, by means of which the surgical site can be monitored. The optical system 15 can be a camera or other image transmission device having an optical system and lighting.

[0028] Instead of the cystoscope 10 , an endoscope can also be used which comprises an additional working channel, for example a channel instead of the optical system 15 , through which instruments can be introduced into the body cavity 14 , whereby the removal device 11 can optionally be placed simultaneously in the working channel 13 .

[0029] Such instruments may be, for example, electrosurgical instruments with wire electrodes, ring electrodes, etc., with the aid of which tissue portions can be separated from other tissue complexes. The retrieval bag serves to receive and securely seal such tissue portions, which—securely contained in the retrieval bag—can then be removed from the body cavity 14 through the working channel 13.

[0030] exist Figure 2 1 shows the removal bag 12 separately. The removal bag preferably includes two flat side walls 16, 17, which can be made of, for example, a thin, flexible plastic material (e.g., a plastic film), such as polyethylene or the like. The side walls 16, 17 are contoured and merge into one another at an edge 18 or are connected there so that they can be laid flat on top of one another.

[0031] The side walls 16, 17 are connected at the top to a closure 19 which is configured, for example, as a profile strip closure and for this purpose comprises, for example, two complementary strips 20, 21. The strip 20 is, for example, C-shaped in cross section. Figure 3 and thus comprises two elastic legs which delimit the channel 22 between each other. The strip 21 is preferably formed of a circular profile, such as Figure 4 As shown in FIG, it fits into the channel 22 between the resilient legs 23,24.

[0032] The straps 20, 21 of the closure 19 are preferably made of flexible plastic. Figure 2As shown in FIG, the straps are slightly arched in the relaxed position so that they open a filling opening 25 on the removal bag 12. Figure 2 The filling opening 25 is shown in the open position. However, if the two strips 20, 21 are interlocked along their respective entire lengths, the retrieval bag 12 is closed and the closure device 19 is then in the closed position. However, due to the curvature of the strips 20, 21 in the relaxed state, the closure device 19 is biased towards its open position, as indicated by Figure 2 However, if the retrieval bag is closed, the underlying rigidity of the side walls 16, 17 results in a tendency for them to abut against one another, whereby the interior enclosed by the retrieval bag 12 has a tendency to collapse.

[0033] The bag 12 can be removed completely or (as Figure 1 and Figure 2 ) is only partially composed of a hydrophilic, water-permeable filter membrane 26, which covers a section 27 of the removal bag 12 or its side wall 17. If necessary, the same or similar filter membrane 26 can also be provided on the other side wall 16.

[0034] exist Figure 5 1 and 2. The filter membrane 26 is shown separately in FIG. The filter membrane is arranged on the window 28 of the otherwise preferably water-impermeable side wall 16 and is firmly connected to the edge of the window 28. For example, the filter membrane can be arranged on the inwardly facing side of the side wall 16 or 17 and can be glued or welded to the edge of the window 28.

[0035] The filter membrane 26 may be a fleece or a porous film, and may include or consist of one or more materials selected from the following group:

[0036] Polyethersulfone (PES), acrylic polymers, polyamide (PA) or polyethylene terephthalate, polysulfone (PS), hydrophilized polytetrafluoroethylene (PTFE), cellulose acetate (CA), cellulose nitrate (CN), cellulose acetate and cellulose nitrate (MCE), nylon (NY), polycarbonate (PCTE) and / or polyvinylidene fluoride (PVDF).

[0037] Alternative filter materials are possible, provided they are composed of hydrophilic materials or materials with a hydrophilic coating or finish. Pores extend through the filter material, extending from one flat side of the filter membrane to its other flat side, thereby forming a fluid path through which water can escape from the interior of retrieval bag 12 into the surrounding environment. The upper limit of the pore size is preferably below 12 μm, and thus below the cell size of tumor cells. Preferably, the maximum pore diameter is at most 5 μm, more preferably at most 3 μm or less. Preferably, the pore size is only slightly below a value of 0.2 μm. In a particularly preferred embodiment, the pore diameter is greater than 0.2 μm.

[0038] As from Figure 2 As can be seen in FIG, the retrieval bag 12 is provided with a pulling means 29, such as a plastic line or rope, which is preferably connected to a corner of the retrieval bag 12 where the closure device 19 ends. The pulling means 29 comprises a length greater than the length of the endoscope or cystoscope 10 so that the retrieval bag 12 can be pulled in accordance with the embodiment of the present invention. Figure 1 The end of the traction element 29 of the retrieval bag 12 is accessible from the outside (outside the patient). The traction element 29 extends through a push rod 30, which can be tubular and includes a longitudinal cutout 31 at its distal end. The longitudinal cutout is dimensioned such that if the retrieval bag is pulled into the longitudinal cutout 31 by means of a relative movement between the push rod 30 and the traction element 29, the closure device 19 is closed, i.e., the strips 20, 21 are pressed into each other in a snap-fit ​​manner. Preferably, the traction element 29 is flexible and can therefore transmit traction forces, but not thrust forces.

[0039] The retrieval device described so far operates as follows:

[0040] To remove tissue, retrieval bag 12 can first be coiled and positioned before or within end 32 of push rod 30, with traction member 29 extending through or along push rod 30. With the aid of push rod 30, the coiled retrieval bag 12 is then pushed through working channel 13 of endoscope or cystoscope 10 and into the patient's body cavity 14. Upon exiting working channel 13 of endoscope or cystoscope 10, retrieval bag 12 is released, causing filling opening 25 to open the interior of retrieval bag 12. Straps 20, 21 spring away from one another, further expanding the space between side walls 16, 17. The surgeon can now remove tissue from the surgical site in one piece, for example using other instruments guided through other working channels 15, and transfer it through filling opening 25 into retrieval bag 12. Once this procedure step is complete, push rod 30 is moved distally, thereby maintaining traction member 29 in an axially fixed position, preventing bag 12 from following the axial movement of push rod 30. Thus, the push rod 30 moves over the upper end of the retrieval bag 12 with its longitudinal incision 31 and thereby permanently closes the closure device 19. The closed retrieval bag 12 remains closed and cannot be opened (even unintentionally) in the body cavity 14. The traction device 29 can actually pull the retrieval bag 12 into the longitudinal incision 31, but can no longer push it out. If the proximal end of the traction device 29 is connected to the proximal end of the push rod 30, when the retrieval bag is pulled out of the cystoscope 10 or endoscope through the working channel 13 with the help of the push rod 30, the retrieval bag cannot be pushed out of the longitudinal incision 31. For this purpose, a connecting device can be provided at the proximal ends of the push rod 30 and the traction device.

[0041] Due to the rigidity of the side walls 16, 17 and / or the rigidity of the filter membrane 26, the interior of the retrieval bag 12 now tends to decrease in volume. Liquid, particularly water or aqueous substances, removed from the body cavity 14 and present in the retrieval bag 12 can escape from the retrieval bag 12 through the hydrophilic filter membrane 26. However, the removed tissue remains within the retrieval bag 12. The latter can now be carefully deflated, for example, by coiling it around the end of the push rod 30 by rotating it and retracting it through the working channel 13. The retrieval bag can also be removed from the patient together with the endoscope or cystoscope 10.

[0042] A modification of the present invention is possible. For example, according to Figure 6 Instead of one window 28 in the side wall 17, a plurality of smaller windows 28a, 28b, etc., covered by the filter membrane 26, can be provided. In addition, instead of a single filter membrane 26, a plurality of filter membranes 26a, 26b can be provided. The filter membranes 26a, 26b can be regarded as layers of filter membranes, whereby the centrally perforated side wall 17 forms a support. Alternatively, according to Figure 5 The filter membrane 26 or according to Figure 6 The filter membranes 26a and / or 26b can each have a multilayer structure. The individual layers can be made of the same or different materials, which can be selected from the above-mentioned material list. Other materials with similar functions are also possible. They can be stacked directly on top of each other or arranged at a distance from each other. In particular, many membranes can be provided by individual films with openings larger than tumor cells, for example (also significantly) larger than 12 μm. By connecting multiple such films in a layered manner with different orientations, a composite membrane with smaller openings is produced due to the superposition of the individual films. This simplifies production and reduces the resistance of the water flowing through.

[0043] exist Figure 7 shows another embodiment. There, the retrieval bag 12 is equipped with a wringing device 33. The wringing device can be configured, for example, as a rigid, finger-shaped extension 34 or as a top cap, which extends distally away from the cystoscope 10 or endoscope. In an endoscope, instead of this extension, a corresponding rod can be inserted through the working channel 15, the distal end of which forms or replaces the extension 34. If the push rod 30 is rotated, the fingers 34 hinder the rotation of the retrieval bag 12 and thus force water out of its interior, which can then pass through the filter membrane 26.

[0044] According to the present invention, for removing tissue, particularly pathogenic tissue, from a patient's body cavity, a retrieval device is provided comprising a retrieval bag 12, which is entirely or partially composed of a hydrophilic, water-permeable filter membrane 26. Filter membrane 26 preferably has a pore width of less than 12 μm, more preferably less than 8 μm, and preferably less than 5 μm, to reliably prevent the passage of pathogenic cells or other pathogenic material. However, the pores are at least large enough to allow water to easily escape from retrieval bag 12. In this way, when filled, retrieval bag 12 only requires the volume occupied by the contained tissue to be removed. Liquid contained within retrieval bag 12 can drain from the retrieval bag through filter membrane 26, thus without increasing its volume. This allows relatively large tissue masses to be accommodated during tumor removal. Thus, the tumor can be removed as a whole, without having to separate it within the body cavity. This significantly reduces the risk of malignant tissue spreading and the associated risk of recurrence.

[0045] Reference numerals

[0046] 10 Cystoscopy

[0047] 11 Removal device

[0048] 12 Take out the bag

[0049] 13 working channels

[0050] 14 Body cavity

[0051] 15 working channels / optical system

[0052] 16,17 Remove the side wall of bag 12

[0053] 18 Edge

[0054] 19 Closure device

[0055] 20 Strip with legs 23, 24

[0056] 21 strips

[0057] 22 channels

[0058] 23 Legs

[0059] 24 Legs

[0060] 25 Filling opening

[0061] 26 filter membrane

[0062] 27 Remove the section of bag 12

[0063] 28 Window

[0064] 29 traction device

[0065] 30 putts

[0066] 31 longitudinal incision

[0067] 32 distal end of the push rod 30

[0068] 33 Wringing device

[0069] 34 fingers.

Claims

1. A retrieval device (11) for removing tissue from a human or animal patient, having a retrieval bag (12) including a filling opening (25), A pulling device (29) connected to the removal bag (12) is provided, It is characterized by: The removal bag (12) comprises at least one section (27) consisting of a hydrophilic, water-permeable filter membrane (26). The hydrophilic, water-permeable filter membrane (26) comprises an arrangement of one or more layers (26a, 26b) of the same or different filter materials. Wherein, the filter material is flannel or porous film, and wherein the filter material has a pore size of less than 5 μm, wherein the filling opening (25) is provided with a closing device (19), wherein the closure device (19) is a profile strip closure having two strips (20, 21), wherein one strip (20) is C-shaped in cross section, and wherein the other strip (21) comprises a circular profile matching the C-shaped cross section of the strip (20), wherein the strips (20, 21) are configured to establish a snap connection when the round profile of the strip (21) is pressed into the C-shaped cross-section of the strip (20), A push rod (30) is provided which has a longitudinal cutout (31) and is associated with the closure device (19), wherein a part of the removal bag (12) including the closure device (19) can be pulled into the longitudinal cutout by means of the pulling means (29) in order to close the closure device (19) by creating the snap connection between the two strips (20, 21) due to the relative movement between the strips (20, 21) and the push rod (30).

2. The removal device according to claim 1, characterized in that: The pulling means (29) are flexible and can therefore transmit pulling forces but not pushing forces.

3. The removal device according to claim 1 or 2, characterized in that: The closure device (19) comprises an open position and a closed position, and the closure device (19) is biased toward its open position.

4. The removal device according to claim 1 or 2, characterized in that: The retrieval bag (12) comprises two flat side walls (16, 17).

5. The removal device according to claim 4, characterized in that: If the retrieval bag (12) is closed, the side walls (16, 17) are biased towards each other.

6. The removal device according to claim 1 or 2, characterized in that: The removal bag (12) is equipped with a wringing device (33).

7. The removal device according to claim 1 or 2, characterized in that: The retrieval bag (12) includes at least one water-impermeable section.

8. The removal device according to claim 7, characterized in that: The water-impermeable section is formed by a plastic film.

9. The removal device according to claim 1, characterized in that: The filter material is selected from the group consisting of polyethersulfone, acrylic polymer, polyamide or polyethylene terephthalate, polysulfone, hydrophilized polytetrafluoroethylene, cellulose acetate, cellulose nitrate, cellulose acetate and cellulose nitrate, polycarbonate, and polyvinylidene fluoride.

10. The removal device according to claim 1, characterized in that: The filter material has a pore size of less than 3 μm.

11. The removal device according to claim 1, characterized in that: The filter material has a pore size of less than 2 μm.

12. The removal device according to claim 1, characterized in that The filter material has a pore size of less than 1.2 μm.

13. The removal device according to claim 1, characterized in that The filter material has a pore size of less than 0.8 μm.

14. The removal device according to claim 1, characterized in that The filter material has a pore size of less than 0.65 μm.

15. The removal device according to claim 1, characterized in that The filter material has a pore size of less than 0.45 μm.

16. The removal device according to claim 1, characterized in that The filter material has a pore size of less than 0.2 μm.

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