Tissue Receiving Bag and Set for Surgery Comprising a Tissue Receiving Bag
20200352599 ยท 2020-11-12
Inventors
Cpc classification
A61B17/3439
HUMAN NECESSITIES
A61B17/3462
HUMAN NECESSITIES
A61B90/40
HUMAN NECESSITIES
A61B2017/320024
HUMAN NECESSITIES
International classification
Abstract
The invention relates to a tissue receiving bag for use in surgery, especially laparoscopic surgery, wherein the bag comprises at least one tissue receiving opening for receiving tissue and/or an instrument opening, especially a morcellator opening, wherein the bag comprises at least one further opening into the bag, wherein a flexible tube extends from said further opening having a free end comprising an insertion opening for inserting an instrument into the bag, wherein the bag preferably is inflatable.
Claims
1. Tissue receiving bag for use in surgery, wherein the bag comprises at least one tissue receiving opening for receiving tissue or an instrument opening, wherein the bag comprises at least one further opening into the bag, wherein a flexible tube extends from said further opening having a free end comprising an insertion opening for inserting an instrument into the bag, wherein the free end prior to insertion into a human or animal body comprises at least one closing element for closing the free end of the tube.
2. Tissue receiving bag according to claim 1, wherein the closing element is configured for sealing the tube around an instrument inserted into the tube through the free end.
3. Tissue receiving bag according to claim 1, wherein in an extended state of the tube the tube has a length suitable for during use bringing the free end of the tube outside a human or animal body through a laparoscopic incision when the bag has been inserted into a body cavity of the human or animal body.
4. Tissue receiving bag according to claim 1, wherein the bag is inflatable.
5. Tissue receiving bag according to claim 1, wherein the closing element is at least one of a tube portion, a closure or a valve.
6. (canceled)
7. Tissue receiving bag according to claim 1, wherein the tube comprises at least two closure elements, longitudinally spaced apart, for closing the tube or sealing against an instrument extending through said tube.
8. Tissue receiving bag according to claim 1, wherein the bag is provided with a series of further openings, wherein a flexible tube extends from each further opening, each of said tubes provided with at least of said closing element.
9-11. (canceled)
12. Tissue receiving bag according to claim 1, wherein a further tube extends from or defines the instrument opening, which further tube comprises a closure or seal for closing or sealing the tube around an instrument extending through said tube or for closing the tube when such instrument is retracted from said instrument opening.
13. Tissue receiving bag according to claim 1, wherein the bag has a tissue receiving opening and an instrument opening, spaced apart from the tissue receiving opening.
14. Tissue receiving bag according to claim 1, wherein the bag is suitable for at least one of: introduction into a human or animal body through a first opening in the body; introducing tissue into the bag through the tissue opening; pulling a free end of the at least one tube out of the body through a second incision; introducing a morcellator into the bag through the instrument opening; or introducing a further instrument into the bag through the free end of the tube.
15. Tissue receiving bag according to claim 14, which is further suitable for at least one of: containing morcellated tissue inside the bag; closure of the free end of the at least one tube outside the body; retracting the at least one tube into the body through the second incision; and retracting the bag from the body through the first opening.
16-19. (canceled)
20. Tissue receiving bag for use in surgery, wherein the bag comprises at least one tissue receiving opening for receiving tissue or an instrument opening, wherein the bag comprises at least one further opening into the bag, wherein a flexible tube extends from said further opening having a free end comprising an insertion opening for inserting an instrument into the bag, wherein prior to insertion into a human or animal body the free end is closed by at least one of a tube portion, a closure or a valve.
21. Tissue receiving bag according to claim 20, wherein the flexible tube prior to insertion of the bag into the human or animal body extends from the wall of the bag, from said further opening to said tube portion, closure or valve.
22. Tissue receiving bag according to claim 20, wherein the bag is inflatable.
23. Tissue receiving bag according to claim 20, wherein the tube has been formed prior to insertion of the bag into the human or animal body.
24. Tissue receiving bag according to claim 20, wherein a further tube extends from or defines the instrument opening, which further tube comprises a closure or seal for closing or sealing the tube around an instrument extending through said tube or for closing the tube when said instrument is retracted from said instrument opening.
25. Tissue receiving bag according to claim 20, wherein the bag has a tissue receiving opening and an instrument opening, spaced apart from the tissue receiving opening.
26. Tissue receiving bag for use in surgery, wherein the bag comprises at least one tissue receiving opening for receiving tissue or an instrument opening, wherein the bag comprises at least one further opening into the bag, wherein a flexible tube extends from said further opening having a free end comprising an insertion opening for inserting an instrument into the bag, wherein the further opening comprises a self-closing closure or seal for sealing around an instrument inserted through said further opening.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] In further elucidation of the present invention embodiments of the present disclosure, such as embodiments of a tissue-receiving bag, an operating set and an operating method shall be described hereafter, with reference to the drawings. In the description a tissue-receiving bag may also be referred to as a morcellator bag. Therein shows:
[0028]
[0029]
[0030]
[0031]
[0032]
[0033]
DETAILED DESCRIPTION
[0034] In this description, embodiments of the invention will be described with reference to the drawings by way of example only. These embodiments should by no means be understood as limiting the scope of the disclosure. At least all combinations of elements and features of the embodiments shown are also considered to have been disclosed herein. In this description the same or similar elements and features will be referred to by the same or similar reference signs.
[0035] In this description expressions of orientation such as top, bottom, vertical et cetera are used for convenience only and refer to the orientation of the module as seen in the accompanying drawings. Such expressions are not to be regarded as limiting the orientation of the module in use, and indeed, as will be described below, bags and instruments such as morcellators according to the description can be used in other orientations.
[0036] A tissue receiving bag 1 according to the disclosure can be used for surgery, especially but not limited to laparoscopic or minimal invasive surgery, for removal of tissue from a human or animal body, such as for example but not limited to hysterectomy, removal of cancerous and/or benign tissue or cists, or of organs. Tissue may for example and not exclusively be all or part of the uterus, ovaries, fibroids, spleen, kidneys, intestine, or any dissected tissue to be removed safely from said body.
[0037] A tissue receiving bag according to this disclosure can preferably be closed during and after surgery such that at least all parts of the bag, including the or each tube, that pass into and/or through the body of a patient are firmly closed when tissue is treated inside the bag and retrieved from the body from the bag or with the bag, whereas the at least one additional tube provides access into the bag when so desired. No tissue matter can therefore escape into the body from the bag when the tissue receiving opening has been closed.
[0038]
[0039] As shown in
[0040] In this description a tube 5 should be understood as meaning at least a tubular element which is at least partly flexible and preferably made of plastic or rubber. A tube 5 can be an integral part of the bag 1 or can be connectable to the bag 1, for example using a known coupling element, or can be mounted to the bag 1, for example by sealing, welding, gluing or any other suitable means. A tube 5 can for example be pleated, such that in a first position, as for example shown in
[0041] The free end 6 of the tube 5 may be provided with at least one closing element 10 for closing the free end 6 of the tube 5 and preferably for sealing the tube 5 around an instrument 8 when inserted into the tube 5 through the free end 6 or at least through the insertion opening 7. Such closing element 10 can for example be a tie rope or an elastic band. In embodiments the closing element 10 can comprise a gel port or the like self-closing element. Preferably the element 10 closes air tight around the instrument. In embodiments the end 6 can be provided with a seal 10 cooperating with a seal provided on the instrument 8, for example comparable to a Luer lock-type connection.
[0042] In embodiments the free end 6 of the tube 5 is closed, at least prior to use of the bag 1, by at least one of a tube portion, a closure or a valve. In an embodiment the free end 6 may be closed by part of the tube 5 itself, for example a seal of the tube such as shown in
[0043] In embodiments the further opening 4 can comprise a closure 11. The closure 11 preferably is a self-closing closure or seal for sealing around an instrument 8 inserted through said further opening. Such closure 11 can for example be a gel port, as known in the art, or a duck bill type valve as shown in
[0044] In embodiments the tube 5, especially at least the free end thereof can be designed such that after removal of the instrument 8 from the tube 5 the free end 6 can be closed again, in order to avoid gas and/or fluids and, especially, bodily tissue such as but not limited to body cells leaving the bag through said tube 8. In embodiments the closing 10 as discussed can be used for reclosing said end 6. The closing element 10 can for example be an elastic band or string that can be pulled tight around the instrument 8 and after removal of the instrument. In embodiments a closure element 10 can be a self-closing element, such as a duck bill type valve, which can be pushed open when inserting an instrument 8 but will be pushed closed, for example by gas inside the bag, when the instrument is not present in the tube 5.
[0045]
[0046] During use after removal of an instrument 8 from the tube 5 first the free end 6 can be folded or pushed inward back into the tube 5 after which a closure 10, especially one of at least two closures 10, especially the second closure 10B can be closed or pulled tight, closing the tube 5 and securing the free end 6 inside the tube 5. Since the only part of the tube 5 that could be in contact with the instrument 8 and might thus be contaminated with for example body cells is the inside of the tube 5 and possibly the edge of the insertion opening 7 or a directly adjacent part of the free end 6, by confining this inside the tube itself, closed off from the environment, contamination of the environment is prevented.
[0047] If two closures 10A, 10B are provided, one of the closures 10A, especially the closure closest to the opening 4 can be closed before the instrument 8 is fully retracted (
[0048] In embodiments the bag is provided with a series of further openings 4. A flexible tube 5 can extend from some or each further opening 4. In embodiments each further opening 4 can be spaced apart from the tissue receiving opening 2 and from the instrument opening 3. This will ease working on tissue within the bag 1 with different instruments, such as a morcellator and for example a camera, scissors, graspers or the like, from different angles.
[0049] The tissue receiving opening 2 is preferably provided with a closing mechanism 12 for closing the opening 2 after tissue T has been received inside the bag 1. Such closing mechanism can for example be a zipper, Ziploc type closure, adhesive strips, Velcro type locking or any such suitable means for closing the opening 2, preferably air and liquid tight. Alternatively or additionally the bag 1 can be foldable such that the opening 2 can be closed after receiving the tissue T.
[0050] In embodiments a further tube 13 can extend from or can define the instrument opening 3. Said further tube 13 and/or the instrument opening 3 can comprise a closure and/or seal 14 for closing and sealing the tube 13 around an instrument 15 extending through said tube and/or for closing the tube 13 when such instrument 15 has not been inserted into the opening 3 or is retracted from said instrument opening 3. The tube 13 will have a longitudinal length L13 making it easy to keep an end 16 of the tube 13 outside the body or at least outside an incision 9 through which the bag 1 is inserted, in order to provide easy access into the bag 3, easy connection to the bag 1, for example for instrumentation or for removal of the bag 1 from a cavity C. Moreover this may prevent contamination of the incision 9 when an instrument 3 is retracted or when the bag 1 is removed.
[0051] In embodiments a closure and/or seal 14 at the opening 3 of the bag 1 can be an integral part of the bag 1. In embodiments a closure and/or seal 14 at the opening 3 can be a multi port closure as conventionally used with tissue receiving bags 1 of the prior art. Such multi port closure is for example known from WO2013/093030. Such closures are well known in the art, such as for example but not limited to TriPort15 or SILS ports.
[0052] In preferred embodiments a tissue receiving bag 1 according to the disclosure is suitable for at least introduction into a human or animal body B through a first opening in the body, especially a first incision 9, introducing tissue T into the bag through the tissue opening 2 and closing the tissue opening 2. A free end 6 of at least one tube 5 can then be pulled out of the body B, preferably through a second incision 17, especially a second laparoscopic incision 17. The free end can thereby be brought outside the cavity C and preferably also outside the body B. During surgery then at least part of an instrument such as for example a morcellator 15 can be introduced into the bag 1 through the instrument opening 3, whereas a further instrument 8 can be introduced at least in part into the bag 1 through the tube 5, by inserting it through the opening 7 of the tube 5. If several such tubes 5 are provided several entries into the bag can be created in this way.
[0053] Preferably the bag 1 is further suitable for morcellation of and/or otherwise treating the tissue T inside the bag and containing morcellated tissue T inside the bag 1. Preferably the free end 6 of the at least one tube 5 outside the body B can be closed during and/or after retraction of the relevant further instrument 8 from said tube 5, preferably gas and liquid tight. Then the at least one tube 5 can be retracted into the body through the relevant second incision 17, back into the cavity C in which the bag 1 is situated. The bag 1 can be retracted from said cavity C and the body B through the first opening or incision 9. Since the free end 6 of the tube 5 has been closed prior to retraction into the cavity, contamination of the cavity C by any tissue related matter, such as cells is prevented, since this matter cannot leave the bag 1.
[0054] Alternatively the instrument opening 3 can be closed and the bag be retracted through the same or a second incision 17 or further incision or natural or man made body opening.
[0055] It is preferred that the instrument 8 is retracted into the tube 5 in part, such that it can be closed between an end 8 of the instrument closest to the main volume V of the bag 1 and said main volume V, before retracting the instrument fully from the tube, preventing matter, such as tissue cells being forced out of the bag before closing the tube 5. Then, when the instrument 8 has been retracted fully, preferably the free end 6 of the tube 5 is inserted into the tube 5, for example pushed or folded back, where after the tube 5 is again closed at the then free end 6A thereof, containing the original free end 6 within the tube 5, between the two closures. Thus contamination of the body B with matter from the bag is even better prevented, especially during retraction thereof into the cavity C and when being pulled out through the first opening or incision 9. For such method especially but not exclusively a bag 1 as for example shown in
[0056] In embodiments the bag 1 can be inflatable. In embodiments the bag 1 can be inflatable by inserting gas such as air into the internal volume V of the bag 1, for example through one of the openings 2, 3, 7. Obviously such bag 1 then preferably is air tight, including closures of all relevant openings. By inflating the bag 3 the internal volume V of the bag 1 can be kept open, which at least facilitates working inside the bag 1 by creating a substantially unobstructed working area. Moreover this reduces the risk of the instruments 8, 15 damaging the bag 1, especially puncturing the wall 18 of the bag 1 since the bag 1 will be expanded.
[0057] In embodiments, as for example shown in
[0058] According to the invention an operating set, especially for laparoscopic surgery can comprise a bag according to any one of the previous claims and at least one morcellator instrument, wherein the bag and/or the instrument comprise at least one indicator for preventing the morcellator puncturing the bag.
[0059] In embodiments of a tissue receiving bag, such as a bag 1 as disclosed in this description or as known in the art, at least part 18C of a wall 18 of the bag 1 is electrically conductive. An instrument 8, 15, such as a morcellator, to be used inside the bag 1 can then be provided with at least one appropriate contact 20, such that when said contact 20 is brought into contact with the electrically conductive wall part 18 an electric circuit is closed and an alarm 25 given, for example audible and/or visible, and/or the instrument is shut off. This can for example be indicative for a situation in which a part of the instrument 8, 15 is too close to said wall, risking puncture or otherwise damage of the bag 1. Alternatively or additionally said sensor can be or comprise a contact or pressure sensor. Alternatively or additionally the wall 18 of the bag 1 can for example be at least partly reflective for electromagnetic waves, such as but not limited to light or sound, e.g. ultra sound, transmitted from a transmitter 21 provided on the instrument 8, 15, wherein a sensor 22 is provided for receiving waves reflected from said reflective wall part 18. Based on the waves detected by said sensor 22 then the distance of a relevant part of the instrument 8, 15, for example the distance between the wall 18 of the bag 1 and a morcellator head 15A can be deduced, which can again be indicative for a situation in which a part of the instrument 8, 15 is too close to said wall, risking puncture or otherwise damage of the bag 1. This can be used for example for giving an alarm 25 and/or for shutting off the instrument 8, 15.
[0060] In more general terms an operating set 23 of a tissue receiving bag 1 for example but not limited to a bag 1 according to this disclosure and an instrument 8, 15 can be designed such that at least one of the bag 1 and/or the instrument 8, 15 comprise at least one indicating system 18, 20, 21, 22 for preventing the instrument 8, 15, especially a morcellator puncturing the bag 1. This may prevent the risk of tissue and/or body fluids, such as morcellated tissue, cells or the like to leak from the bag 1 back into the body, which could result in infection or spreading cells which may be cancerous or otherwise detrimental to the patient's health.
[0061] In these embodiments the indicating system 18, 20, 21, 22 can be designed to measure or otherwise detect a distance between a cutting or puncturing end of the relevant instrument and a wall part 18 of the bag 1 close thereto, such that if said distance is reduced below a predefined limit an alarm is given and/or the instrument 8, 15 is shut off or is otherwise prevented from damaging said wall of said bag. The said limit may be zero, meaning that said alarm is given or said instrument is shut off or brought into an idling state when a relevant part of the instrument contacts the wall of the bag. For example as long as said instrument contacts said bag.
[0062] An operating set 23 according to this disclosure can comprise a tissue-receiving bag 1 and at least one instrument, especially a morcellator 15. Such an operating set can further comprise at least one further instrument 8 insertable through a tube 5 and a further opening 4 of the bag 1. The further opening 4 and/or the tube 5 can preferably be sealingly closed around said further instrument 8 when extending through said tube 5 and/or further opening 4. Such further instruments can for example be one of but not limited to an endoscope, a camera, a catheter, a cannula, grasper or scissors. An example of a morcellator can be a Storz morcellator.
[0063] With an operating set 23 according to the disclosure surgery can be performed, for example as follows.
[0064] After proper preparation of a patient 30 a first incision 9 is made in the body B, opening into a body cavity C. The tissue-receiving bag 1 is folded and then introduced into the cavity C through the first incision 9. The instrument opening 3 is held outside the cavity C, a part of the bag 1, for example a further tube 13 forming a neck portion of the bag 1 extending through the incision 9. Tissue T to be removed, for example and not limited to all or part of the uterus, ovaries, fibroids, spleen, kidneys, intestine, or any dissected tissue to be removed safely from said body, is cut from the body B inside the cavity, for example by introducing a dissecting instrument 8A into the body cavity C through a second incision 17, in a known manner. The tissue T preferably is held by an appropriate instrument 8B, such as graspers, during dissection, in order to manipulate the tissue during dissection and to prevent the tissue T from dropping in the cavity C. In embodiments the instrument 8B can be inserted into the body cavity C through a third incision, but preferably the said instrument 8B is inserted through the instrument opening 3 or through a further opening 4, extending through the bag 1 and out of the tissue receiving opening 2, such that after dissection the tissue can be retracted into the bag 1 through the tissue receiving opening 2 without for example having to transfer it to a further instrument. In embodiments the bag could be moved over the tissue to be dissected prior to dissection, by moving the tissue-receiving opening over the tissue T and dissecting the tissue T inside the bag. In such embodiment the dissecting instrument 8A could also be inserted into the bag through the instrument opening 3, or through a further opening 4, preferably in a manner as will be described hereafter.
[0065] After having received the tissue T inside the bag 1, the tissue receiving opening 2 is closed, for example by the closing mechanism 12. Preferably the closure can be manipulated from the inner volume V of the bag 1. Alternatively the closure can be manipulated at least partly from the outside of the bag 1, for example by introducing an appropriate instrument such as graspers through a further incision.
[0066] On the instrument opening 3 preferably a closure 14 is provided, such as for example a multi port closure as indicated before, closing and sealing the opening 3. The bag 1 preferably is inflated by introducing a gas such as air into the interior volume V and/or, if a multi-layered wall is used, between two such layers 18A, B, as described. This will provide a large inner volume V of the bag 1 allowing the surgeon(s) sufficient space to manipulate the tissue T inside the bag without being obstructed by the wall 18 of the bag 1. The wall 18 of the bag 1 may push outward the wall of the cavity C.
[0067] The dissecting instrument 8A will be retracted from the second incision 17. An appropriate instrument, such as for example, graspers, will be inserted through a second incision 17, with which instrument an end 6 of a tube 5 will be grasped such that it can be pulled out through the second incision 17, such that the tube 5 passes the incision and free end 6 extends outside said body B or at least outside the cavity C. If the end 6 and/or the opening 4 from which the tube extends is closed no gas or tissue can leave the bag through said tube 5. Such closure can for example be obtained by one of the closures 10 or by an appropriate closure at the opening 4, for example but not limited to a gel port or a duck bill type valve, as known from the art and for example described in WO2013/075103.
[0068] The free end 6 outside the body B may be severed, for example be cut off, providing an opening 7 into the tube 5. Then an instrument 8, such as for example but not limited to graspers, scissors, endoscope, light source, suction device, flushing device, cannula, catheter or the like can be inserted into and through the tube into the inner volume of the bag 1. The instrument 8 will be shielded relative to the cavity C by the tube 5 and the bag 1. Preferably the tube 5 seals against an outside of the instrument 8 or appropriate seals are provided, for example a single or multi port closure 14A provided by or mounted on the opening 7 or in the opening 4, preventing gas and/or tissue such as cells or fluids to pass along the instrument 8.
[0069] Obviously more than one such tube 5 can be pulled through one or more incisions 9, 17, in a similar way, in order to provide different points of access into the bag 1 for instruments to be used during surgery. Each incision 9, 17 is preferably a laparoscopic, minimal invasive incision.
[0070] After closure of the bag 1, especially the tissue receiving opening 2, and preferably after inflating the bag 1, a morcellator 15 can be inserted into the inner volume V of the bag 1, in order to morcellate the tissue T inside the bag. Such morcellators (both electromechanical and bipolar cutting) are well known in the art and shall not be discussed here in any detail. In embodiments during morcellation of the tissue the morcellated tissue can be retrieved from the bag 1, for example by suction and/or extraction with graspers through the morcellator itself and/or through a suction instrument inserted into the bag through a tube and further opening 4. Alternatively, the tissue, before, during and after morcellation can be contained by the bag 1, inside the inner volume thereof, to be removed from the cavity together with the bag 1.
[0071]
[0072] When an instrument 8 is no longer necessary for use in the bag 1 it may be retracted from the relevant tube 5. Preferably, to this end firstly the instrument 8 is retracted following the procedure as described with reference to
[0073] When the bag 1 is to be retrieved from the cavity C any tube 5 used will be closed as discussed. Then the bag 1 can be retrieved by pulling it out of the cavity C through one of the incisions 9, 17. Preferably the bag 1 is retrieved through the largest incision or the least conspicuous incision. The bag may also be inserted and/or retrieved per vaginam, through the Fossa Douglasi or through any orifice appropriate for the performance of the surgical techniques, for example techniques now known as Natural Orifice Translumenal Endoscpopic Surgery (NOTES) surgery. The bag can for example be retrieved through the first incision 9. In such embodiment the or each tube 5 extending through another incision 17 will be pulled back into the cavity C before being pulled out of the cavity C with the bag 1. Since the free ends 6 have been properly closed, the possibly contaminated portions 6A thereof being well shielded, the risk of contamination of the cavity C is substantially eliminated.
[0074] In the embodiments of the method described the instrument opening 3 is kept outside the cavity C during the entire procedure. However it is also possible to first insert the entire bag 1 into the cavity C, dissect the tissue and position it into the bag 1 and then pull the instrument opening 3 back out through the first incision 9. This is especially suitable of the instrument opening 3 is also the tissue receiving opening 2, as is known in the art as for example described in WO2013/075103 and WO2013/093930. In such embodiments again one or more tubes connected to one or more further openings 4 may be pulled through further incision(s) as described here above, before, during and/or after bringing the instrument opening 3 back out through the first incision 9.
[0075] In embodiments for at least one and preferably all of the tubes 5 and/or for the tube 13 a cytotoxic valve or seal, such as for example but not limited to a gel port 36, 36A can be provided, preferably at a position outside the body B during surgery. Such cytotoxic provision can for example be incorporated into or be provided by the ports 14 and/or 14A or as separate provisions. In
[0076] Preferably the cytotoxic provisions are mounted to or connected to or over the free end of the relevant tube 8, 13 outside the body, such that they can be removed from the relevant tube 5, 13 prior to the procedure as described, for example referring to
[0077] As discussed one or each tube 5 may be a part separate from the bag 1 and may be connectable to the bag 1, especially to a further opening 4 permanently or temporarily. In embodiments the tube can be provided with an instrument 8 to be introduced into the bag. As shown in
[0078] The disclosure is by no means limited to the embodiments specifically described and shown in the drawings. Many variations therefor are possible and are also considered disclosed herein, including but not limited to all combinations and permutations of parts of the embodiments as shown and described, which are all considered having been disclosed herein. The bag 1 may be made of any suitable material or combinations of materials. In a bag having a multiple layered wall an inner wall may be more rigid that an outer wall, in order to obtain expansion substantially outward if inflated between the layers. Multiple tissue receiving openings could be provided. A bag 1 could have different compartments, some or all of which may be inflatable, whereas different tissue may be receivable in such compartments.