This application is a National stage application filed under 35 U.S.C. § 371 of International Application No. PCT/DK2018/050087, filed on May 2, 2018, which claims the benefit of Denmark Patent Application No. PA 2017 70293, filed on May 2, 2017, which applications are incorporated herein by reference in their entirety.
The present invention relates to a sampling device for the use with an endoscope having a suction channel and a suction connector in communication with said suction channel, in particular a sampling device being adapted for connection to the suction connector and said sampling device being adapted for connection to a vacuum source.
Such sampling devices are inter alia used in procedures such as bronchial lavage (BL), bronchial wash (BW) or bronchoalveolar lavage (BAL) which are commonly used procedures for obtaining samples of organic material from a lung segment of a patient. This is basically done by flushing a lung segment with sterile water, normally a sterile aqueous saline solution, and then sucking the water into a sample container. More specifically the distal end of an endoscope is advanced to the location in the lung where the sample is to be taken. In bronchoalveolar lavage, the distal end is then pressed into firm engagement against the interior of the lung to help securing the position in a process commonly referred to as wedging.
Via the working channel of the endoscope, sterile water, e.g. a 0.9% saline solution, or isotonic saline, is instilled into the lung at the sample location and as much as possible extracted again, now containing organic material, and thus constituting a sample. Typically, this is done by attaching a filled syringe of a volume between 20 ml and 60 ml, e.g. 50 ml to the working channel of the endoscope, via a communication port in endoscope handle. The syringe is then used for each instillation as well as the subsequent extraction. This process is normally repeated several times in a row with new syringes, e.g. three to four, the samples being suitable for various purposes, depending which number of sample in the sequence they are, because the composition of the organic material varies. If the syringe is used for extraction, the sample would be transferred to a sample container suitable for securing biological material. Upon extraction the sample containers are therefore normally labelled accordingly.
As an alternative to the extraction using the syringe, the extraction may be performed using an external suction and a Lukens trap, e.g. as disclosed in U.S. Pat. No. 4,643,197.
Using a Lukens trap attached to the endoscope in the manner disclosed in U.S. Pat. No. 4,643,197, i.e. interposed in the flexible suction line leading from the endoscope to the vacuum or suction source (the two terms are considered to be synonyms throughout this description), involves several disadvantages when carrying out the procedure. One such disadvantage is that being suspended on the line the operator has only little sense of and attention to the orientation of the trap, as the operators visual focus is on the monitor the major part of the attention is on other part of the procedure e.g. the delicate parts of the procedure within the patient. It therefore does happen that the Lukens trap inadvertently ends up in an orientation where the sample is lost, because it gets sucked out of the trap by the vacuum source or suction. Another disadvantage is that there is a lot of work involved in connecting and disconnecting tubes as well as other parts, if e.g. the operator needs to change between obtaining a sample and suction in order to clean without sampling.
Based on this, it is the object of the present invention to provide a sampling device which renders itself for the use with an endoscope and which does not suffer from the above drawbacks.
According to a first aspect of the invention this object is achieved by a sampling device according to the opening paragraph, in which the sampling device is adapted to be interposed between the suction connector of the endoscope and the vacuum source and for forming a rigid connection with said endoscope when connected to the suction connector thereof.
Forming a rigid connection between the endoscope and the sampling device links the orientation of the sampling device to that of the endoscope. This, in turn, gives the operator a much more immediate and instinctive sense of the orientation of the sampling device, because the orientation follows that of the endoscope, the handle of which the operator has a firm grip.
According to a second aspect of the invention, the object is achieved by a sampling system for the use with an endoscope, said sampling system comprising a sampling device and a sampling container adapted for attachment to said sampling device.
According to a third aspect of the invention the object is achieved by a method for performing a lavage comprising the steps of providing an endoscope, providing a sampling device according to the first aspect of the invention, attaching the sampling device to the endoscope, connecting the sampling device to a vacuum source, inserting an insertion part of the endoscope into a body cavity, administering a saline solution through the endoscope to the body cavity, collecting a sample by drawing fluid from the body cavity through the endoscope and the sampling device.
According to a fourth aspect of the invention, the object is achieved by providing a kit comprising a sampling device according to the first aspect of the invention a saline cartridge or a syringe for saline, at least one sample container.
According to a first preferred embodiment of the sampling device according to the first aspect of the present invention, the sampling device comprises a socket defining an insertion direction adapted to receive the suction connector of the endoscope in said insertion direction for forming said rigid connection, and the sampling device is furthermore adapted to engage the endoscope in a manner preventing rotation around the suction connector. Thereby the good sense of orientation is maintained at all angles.
According to a second preferred embodiment, the sampling device comprises a male connector defining an insertion direction adapted to engage a suction connector socket of the endoscope in said insertion direction for forming said rigid connection, and the sampling device is furthermore adapted to engage the endoscope in a manner preventing rotation around the suction connector. This allows the sampling device to be used with existing endoscopes of the kind provided with a socket or a receptacle, i.e. a female connector, rather than a male connector.
According to a further preferred embodiment the sampling device comprises a valve, preferably shunt valve or a three-way valve for diverting the suction through the sampling device through a sample container. Thus, only when sampling is needed is the suction diverted through the sample container. When not the flow may be shunted around the sample container, allowing the endoscope to be used independently of the attached sampling device, i.e. as if it was not there.
According to a preferred embodiment, the valve actuator is adapted to be operated using a single finger of a hand of the operator and is located in a position on said sampling device which, in the mounted position of the endoscope is accessible and operable by the finger of the hand of an operator with which the operator is gripping the endoscope. This allows the valve actuator to be operated by the operator himself without having to release the grip on the endoscope and removing the hand from the handle, using another hand or relying on additional personnel. This, in turn, facilitates the procedure and keeps number of personnel involved down.
According to another preferred embodiment, the sampling device comprises a sample container connector adapted for connecting a sample container. This allows the sample container to be easily attached, removed, and replaced during the sampling procedure.
According to yet another preferred embodiment, the sample container connector extends in a direction parallel to or coincident with said insertion direction. When, as is the case for many endoscopes, the suction connector extends laterally, i.e. in a direction transverse to the insertion tube insertion direction of the endoscope as defined by the insertion tube thereof (not to be confused with the insertion direction of the connector), this allows the forces applied to be transverse to the insertion direction. This, in turn reduces the risk of undesired translatory motion of the insertion tube of the endoscope within the patient.
According to a further preferred embodiment the sample container connector is adapted to penetrate at least one seal of the sample container. This allows automatic sealing of the sample container upon removal, and thus a reduced risk of spilling the sample or of contaminating it.
According to yet a further preferred embodiment, the sampling device is adapted for single use. This allows the sampling device to be constructed from low cost materials such as plastics, because it needs not be able to withstand the harsh circumstances of cleaning and sterilization, such as the high temperatures of an autoclave.
The invention will now be described in greater detail based on non-limiting exemplary embodiments, and with reference to the drawings on which:
Turning first to
The connector 4 is of a standard type for attaching a flexible suction tube 8, in turn connected to a vacuum or suction source, e.g. the wall suction normally found in hospitals. The connector 4 is generally tubular male connector with a taper to allow easy connection of the flexible suction tube 8 and with circumferential corrugations or barbs allowing a secure connection of the flexible suction tube 8 in a well-known manner. The connector 4 need not be an integral part of the endoscope 1. In some multiple use endoscopes 1 the connector is a separate interchangeable part. Furthermore, in some existing endoscopes 1 the connector is a receptacle or a socket, i.e. a female connector.
However, rather than connecting the flexible suction tube 8 directly to the connector 4, the sampling device 9 according to the invention may be connected to the connector 4. The sampling device 9, in turn, may then be connected to the flexible suction tube 8. The sampling device 9 is thus to be interposed between the suction connector of the endoscope 1 and the vacuum source. For this the sampling device 9 has an identical, similar or at least corresponding connector 10 to which the flexible suction tube 8 may be attached, as indicated in
Apart from having a receptacle 28 for receiving the connector 4, the sampling device 9 furthermore comprises a sample container connector comprising a pair of tubular protrusions 11, 12 adapted to engage and be inserted through the wall of a preferably detachable sample container 13, preferable through openings covered by a membrane. Using a pair of tubular protrusion 11, 12 allow the easy penetration of a suitable sealing, such as lip seals, on the sample container 13.
The tubular protrusions 11, 12 are preferably arranged in such a manner on the sampling device 9 that when the sampling device 9 is correctly attached to the endoscope 1 with the connector 4 in the receptacle 28 of the sampling device 9, the tubular protrusions 11, 12 extend in a direction transversely to the longitudinal direction of the endoscope 1. In this illustrated embodiment where the connector 4 extends itself transversely to the longitudinal direction of the endoscope, this means that the tubular protrusions 11, 12 of the sample container connector extend in parallel with the receptacle 28 and consequently in parallel with the connector 4 of the endoscope 1, i.e. in parallel with the insertion direction or possibly even coincident therewith. This has the advantage that displacements, such as jerks when detaching or attaching the sample container 13 will mainly be in the transverse direction to the endoscope 1 and therefore be less likely to cause any displacement of the endoscope in the longitudinal direction, i.e. the aforementioned endoscope insertion direction. Such longitudinal displacement is undesired as the displacement could cause the tip of the endoscope to move within the patient, which could result in loss of the wedge position and thereby extend the time for the procedure.
Turning now to
Having instilled the saline solution in the patient a liquid sample can now be extracted using the part of the system comprising the endoscope 1, the sampling device 9, the sample container 13 and the flexible suction tube 8 to the vacuum or suction source.
To do so, the operator or another suitable person in the team turns a valve 20 via a valve actuator 21 such as a knob or the like to the position shown in
In
To better control and monitor the suction, the sampling device may optionally have a suction reduction valve 35, with which the operator can reduce the amount of suction provided by the vacuum source, and a manometer or other pressure indicator 36. The pressure indicator, if provided, is preferably located in a position on the sampling device 9 where, in use, it is visible by the operator. This could be next to the valve actuator 21 as shown in
Both the suction reduction valve 35 and the pressure indicator 36 are also schematically shown in
When a sample of suitable volume has accumulated in the sample container 13, the push-button 5 is released, and the valve 22 closes, as it is biased towards a closed state in a well-known manner, e.g. spring loaded.
The sample container may now be removed and possibly replaced with a new and empty one, and the process repeated.
If no more samples need be taken, the valve 20 may be turned to shunt the passage though the sample container 13 via the tubular connectors 11 and 12, corresponding to “Position 2” in
After the sampling procedure is completed the sampling device 9 may simply be disposed of. Accordingly, the sampling device 9 is adapted for single use by being manufactured entirely or at least essentially of plastic materials. That is to say low-cost materials, which need not be able to withstand a cleaning and sterilization process. So even if the endoscope 1 is not a single use endoscope 1, the sampling device 9 may well be.
If both the endoscope 1 and the sampling device 9 are adapted for single use they may be supplied as a kit of parts ready for use in the sampling procedure. This facilitates the harmonization and standardization of the sampling procedure, in turn, making it more efficient and cost efficient.
Furthermore, an opening in the sample container 13 is preferably adapted such that the distal end of the endoscope's insertion tube 3 can be entered into the sample container 13 in order to deliver a sample from e.g. the working channel 19 through the distal end of the endoscope 1. This will be relevant in the event that the working channel 19, or the channel applied for collecting a sample, is blocked e.g. by mucus, phlegm, blood etc. and the material contained in the working channel 19 is needed as a sample. Traditionally such material has been discarded by applying a pressure from the proximal end of the working channel 19, e.g. by pressing water (or air) into the working channel 19 by a connected syringe or saline container, while placing the distal end of the insertion tube 3 at a sterile cloth or paper. But in the event that it is not possible to obtain another sample, it would be an advantage if the material in the working channel 19 could be collected in a sample container 13 instead of being discarded.
This can be achieved by entering the distal end of the endoscope 1 into a sample container 13 and then applying the pressure from the proximal end of the working channel 19. The opening in the sample container 13 for this purpose could be an extra opening (not shown in figures), or it could be an existing opening also applied for the connection to the sampling device 9 through the tubular protrusions 11, 12 of the sample container connector. The opening should preferably be self-sealing to avoid spillage of sample material when the tip of the endoscope's insertion tube 3 has been removed. Also, there should be provided an opening for air pressure to escape from the sample container while the tip of the insertion tube 3 is arranged in the opening. This is to avoid that the applied pressure for removing the blockage from the working channel 19 will also remove the sample container 13 from the tip of the insertion tube 3 in the moment the blockage passes into the sample container 13.
In practice, the operator of the endoscope 1 should remove the insertion tube 3 from the body cavity and from the body as such, when a blockage of the working channel 19 is identified e.g. when suctioning is blocked. The tip of the insertion tube 3 is inserted into the suitable opening in a sample container 13, and a syringe is connected to an entrance to the working channel 19 e.g. at the handle 2 of the endoscope 1. An increasing air pressure is applied to the working channel 19 by the syringe, until the blockage is removed and the material from the working channel 19 enters into the sampling container 13. The tip of the insertion tube 3 is then removed from the sample container 13, and may be reintroduced into the body cavity if necessary.
As mentioned above there is always a risk that the operator may inadvertently orientate the sample container 13 so that the trap does not function, and the collected sample is lost to the suction source through the tubular connector 11 and flexible suction tube 8. Therefore, in addition to being adapted to extend in a well-defined manner from the endoscope 1, because of the cooperation between the receptacle 28 and the tubular connector 4, the sampling device 9 is furthermore adapted to engage the endoscope 1, in particular the handle thereof, in a manner preventing rotation about the tubular connector 4. More specifically, as can be seen from
Turning now to
Turning now to
The endoscope 1 of which only the handle 2 is shown is identical to the one depicted in
As can further be seen from
The flow arrangement through the sampling device 9 and the sample container 13 is essentially the same as shown schematically in
Basically, the use of the sampling device 9 and the sample container 13 are independent on the use of the therefore optional saline cartridge 14 illustrated in
The skilled person will understand that the above description of the sampling device is merely an illustration of preferred embodiments, and that the sampling device may be embodied in many different ways without departing from the scope of the invention. In particular the flow paths, connectors, valves etc. may be devised in many other ways.
Number | Date | Country | Kind |
---|---|---|---|
PA 2017 70293 | May 2017 | DK | national |
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/DK2018/050087 | 5/2/2018 | WO |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2018/202266 | 11/8/2018 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
4643197 | Greene et al. | Feb 1987 | A |
4870975 | Cronk et al. | Oct 1989 | A |
4909782 | Semm et al. | Mar 1990 | A |
4922902 | Wuchinich et al. | May 1990 | A |
4957492 | McVay | Sep 1990 | A |
5290303 | Pingleton et al. | Mar 1994 | A |
5334183 | Wuchinich | Aug 1994 | A |
5347991 | Nakao et al. | Sep 1994 | A |
5363860 | Nakao et al. | Nov 1994 | A |
5409013 | Clement | Apr 1995 | A |
5624418 | Shepard | Apr 1997 | A |
6110127 | Suzuki | Aug 2000 | A |
6190330 | Harhen | Feb 2001 | B1 |
6331165 | Turturro et al. | Dec 2001 | B1 |
6375625 | French et al. | Apr 2002 | B1 |
6632182 | Treat | Oct 2003 | B1 |
6840909 | Gatto | Jan 2005 | B2 |
6852108 | Barry et al. | Feb 2005 | B2 |
7172579 | Barzell et al. | Feb 2007 | B2 |
7708938 | Mariotti et al. | May 2010 | B2 |
7806835 | Hibner et al. | Oct 2010 | B2 |
7963910 | Okada | Jun 2011 | B2 |
8070756 | Secrest | Dec 2011 | B2 |
8088079 | Kaye | Jan 2012 | B2 |
8262565 | Okada | Sep 2012 | B2 |
8303489 | Ito | Nov 2012 | B2 |
8382660 | Okada | Feb 2013 | B2 |
8460182 | Ouyang et al. | Jun 2013 | B2 |
8974399 | Teixeira et al. | Mar 2015 | B2 |
9204868 | Furlong et al. | Dec 2015 | B2 |
9332969 | Han et al. | Jun 2016 | B2 |
9408593 | Furlong et al. | Aug 2016 | B2 |
9421001 | Speeg et al. | Aug 2016 | B2 |
9486185 | Hibner | Nov 2016 | B2 |
9486186 | Fiebig et al. | Nov 2016 | B2 |
9498193 | Smith et al. | Nov 2016 | B2 |
9538994 | Hibner et al. | Jan 2017 | B2 |
9545244 | Parihar | Jan 2017 | B2 |
9603587 | Fiebig et al. | Mar 2017 | B2 |
9713461 | Mikkaichi | Jul 2017 | B2 |
9737285 | Fiebig et al. | Aug 2017 | B2 |
9943291 | VanderWoude | Apr 2018 | B2 |
9968242 | Salman | May 2018 | B2 |
10441206 | Locke | Oct 2019 | B2 |
10667735 | Locke | Jun 2020 | B2 |
11696748 | Johnsen et al. | Jul 2023 | B2 |
20040068291 | Suzuki | Apr 2004 | A1 |
20060235433 | Secrest | Oct 2006 | A1 |
20060287579 | Okada | Dec 2006 | A1 |
20070088199 | Ito | Apr 2007 | A1 |
20070179341 | Okada | Aug 2007 | A1 |
20070191731 | Kaye | Aug 2007 | A1 |
20070213632 | Okazaki et al. | Sep 2007 | A1 |
20080082021 | Ichikawa | Apr 2008 | A1 |
20080163669 | Gregory et al. | Jul 2008 | A1 |
20080183037 | Ichikawa et al. | Jul 2008 | A1 |
20090234192 | Okada | Sep 2009 | A1 |
20100174210 | Han et al. | Jul 2010 | A1 |
20120095369 | Teixeira | Apr 2012 | A1 |
20130123663 | Hibner et al. | May 2013 | A1 |
20130144186 | Furlong | Jun 2013 | A1 |
20140081170 | Parihar | Mar 2014 | A1 |
20140088460 | Teixeira | Mar 2014 | A1 |
20140378864 | Hibner | Dec 2014 | A1 |
20150209491 | Cushner et al. | Jul 2015 | A1 |
20160166239 | Mikkaichi | Jun 2016 | A1 |
20160256139 | Hadley | Sep 2016 | A1 |
20190038195 | Peterson et al. | Feb 2019 | A1 |
20190054217 | Axon | Feb 2019 | A1 |
20200121304 | Johnsen et al. | Apr 2020 | A1 |
20200188921 | Goodman | Jun 2020 | A1 |
20230320708 | Johnsen et al. | Oct 2023 | A1 |
Number | Date | Country |
---|---|---|
102271590 | Dec 2011 | CN |
103153199 | Jun 2013 | CN |
1908391 | Apr 2008 | EP |
2 100 550 | Jan 2011 | EP |
1 813 184 | Jan 2016 | EP |
WO 9908731 | Feb 1999 | WO |
WO 2006039646 | Apr 2006 | WO |
2008144515 | Nov 2008 | WO |
WO 2012051545 | Apr 2012 | WO |
2014028366 | Feb 2014 | WO |
2015031217 | Mar 2015 | WO |
2016196536 | Dec 2016 | WO |
2017075415 | May 2017 | WO |
2017087411 | May 2017 | WO |
Entry |
---|
Global dossier translation of notification of grant from CN application No. 201880028621.7, mailed Feb. 9, 2022, 2 pgs. |
Global dossier translation of office action from CN application No. 201880025464.4, mailed Dec. 28, 2021, 6 pgs. |
Global dossier translation of office action from CN application No. 201880028621.7, mailed Jul. 30, 2021, 7 pgs. |
International Search Report and Written Opinion from corresponding Application No. PCT/DK2018/050086, dated Aug. 22, 2018. |
First Office Action issued in CN201880028621.7, dated Jul. 30, 2021, with informal translation. |
Examination Report issued in EP18722888.7, dated Jan. 13, 2021, 5 pages. |
International Search Report and Written Opinion from corresponding Application No. PCT/DK2018/050087, dated Jul. 3, 2018. |
Danish Search Report from corresponding Application No. PA 2017 70293, dated Jun. 20, 2017. |
Number | Date | Country | |
---|---|---|---|
20220338846 A1 | Oct 2022 | US |