IRRIGATING DEVICE
TECHNICAL FIELD The present invention relates to irrigation devices useful in endoscopic procedures.
BACKGROUND ART A clear field of vision is desirable at all times when performing endoscopy or carry ig out endoscopic procedures in the gut. Due to the nature of endoscopic procedures, the view may be obscured at any time during an endoscopic procedure despite measures taken pre operatively, by food, faeces, blood or secretions. The lens of the camera of the endoscope may be cleared using the normal washing device incorporated in all endoscopes. This water jet is not usually powerful enou-^h to clear the operating field beyond the lens. To do this, an endoscopist will usually use a lar-ge syringe filled with irrigating or tap water, and inject the contents down the operating channel of the endoscope. He/she will then either refill the syringe himself, or an assistant member of endoscopy staff will refill it. At times when there is increased need for irrigation &.g. gastrointestinal haemorrhage, this process involves by necessity a member of staff to "be constantly refilling syringes of water and handing them to the endoscopist where they may "be of more use elsewhere, looking after the patient. This device has been devised in response to this not uncommon situation. Furthermore, there are situations where the instillation of quantities of water down an endoscope may be desirable, and facilitated using this device. Certain centres have described the instillation of 200 - 500ml of water into the left sided colon as a method of easier colonoscopy in training (1,2). Instillation of warm water to relieve colonic spasm, rather tbtan administering drugs with potential side effects, has also been shown to be effective (3). In addition, the insufflation of the bowel with Carbon Dioxide gas (CO2) has been shown to cause less discomfort from trapped air after endoscopic procedures than insufflatL on with room air as CO2 is absorbed by the tissues quicker. This device may also be attached to a low pressure CO2 delivery system to allow insufflation of CO2 when preferred.
DISCLOSURE OF INVENTION The invention includes apparatus for use with endoscopic apparatus, said apparatus comprising or including defining with a housing or housing assembly (""housing").
- -
(A) a first passageway linking first and second ports of the housing, such first passageway being substantially straight, and (B) a second passageway linking a third port to said first passageway, and (C) having a valving arrangement whereby the second passageway either allows or does not allow (at least substantial) fluid and/or gas passage from said third port to said second port, wherein the housing and/or second port is adapted for association with endoscopic apparatus (e.g. adapted directly or indirectly e.g. with a separate linkage) at least substantially to have said third port via the second port in communication with the or an operating channel of such endoscopic apparatus). Preferably the valving arrangement requires intervention from a biased closed condition in order to hold an open condition. A female/female connection member can be used on said second port. In another aspect the invention is an endoscopic assembly comprising or including apparatus as a fluid supply and/or a gas supply connecting to said third port, and an endoscope having an operating channel connecting (directly or indirectly) to said second port, and (optionally) a closure for said first port and/or apparatus to operate through said first passageway into said operating channel. In another aspect of the invention is an endoscopic assembly comprising or including apparatus comprising or including defining with a housing or housing assembly ("housing") a first passageway" linking first and second ports of the housing, such first passageway being substantially straight, and a second passageway linking a third port to said first passageway a fluid and/or gas supply connecting to said third port, an endoscope having an operating channel connecting (directly or indirectly) to said second port, and (optionally) a closure for said first port and/or apparatus to operate through said first passageway into said operating channel, wherein a valving arrangement of the housing and/or the connecting fluid or gas supply can, in use, allow on demand fluid and/or gas supply via said third port and second passageway to the second port and thus into said operating channel.
In still another aspect the invention is a junction assembly associable with an endoscope whereby a controllable irrigation fluid or insufflation gas flow can enter an operating channel of the assembly and, in use, that of the associated endoscope without a need to open the entrance to said operating channel of the assembly or to remove operating or functional apparatus associated thereto or thereinto. In still another aspect the invention is a device having an outlet to communicate
(directly or indirectly) with an operating channel of an endoscope and having an operating channel alignable passageway between first and second ports, and having an irrigation and/or insufflation channel from a third port feeding to said alignable passageway and/or said second port. As used herein the term "and/or" means "and" or "or", or both. As used herein the term "(s)" following a noun includes, as might be appropriate, the singular or plural forms of that noun. As used herein reference to "fluid" and/or "gas" recognises a fluid can be a liquid, gas or both but the use of the different terms is to convey where appropriate an irrigation and/or insufflation function respectively.
BRIEF DESCRIPTION OF DRAWINGS A preferred form will now be described with reference to the accompanying drawings in which Figure 1 is a perspective view from a left side of a device in accordance with the present invention, Figure 2 is a perspective view from the right side of the device of Figure 1, Figure 3 is a side view of the device of Figures 1 and 2, Figure 4 is a top view of the device of the preceding drawings, Figure 5 is a front view of the device of the preceding drawings, Figure 6 is a rear view of the device of the preceding drawings, Figure 7 is an exploded view showing the miscellany of separately moulded parts to be used in the device and showing the optional female/female connection for connecting the second port to an endoscope, Figure 8 is a sectional view of apparatus as aforesaid where the passageway from the third port is open to allow irrigating and/or insufflation apparatus connection thereto to irrigate part of the passageway between the first and second ports, the lever of the valving
arrangement requiring depression to the condition shown in order to act against the compression spring, Figure 9 is a perspective view of apparatus as shown in Figure 8, and Figure 10 shows apparatus substantially as aforesaid ready for use, and Figure 10 is a variant of the arrangement of the earlier drawings showing areas of interest. In the arrangement as shown in Figures 8 and 9, the reference numerals show the following:- I . Master Valve V2 with cutout 2. Plug rectangle 3. Luer lock 4. Luer lock 5. Needle 6. Variceal banding equipment 7. Plug V2 8. Cam 9. Plug for vertical plunger 10. Luer Clip On I I . New Rigid pentax Adaptor 12. CR Kennedy Cap 13. Spring In the preferred form of the present invention as can be seen the moulded parts are as shown in Figure 7. In Figure 7 there is shown the first port I, the second port II and the third port III. Shown by the shape between ports I and II is the first passageway and from port III (via the barrel for the plunger shown in exploded view) the second passageway. This is a disposable plastic device that fits onto the operating channel of an endoscope using a rubber adaptor that can be changed depending on the make of endoscope (Pentax, Olympus or Fujinon). Irrigation fluid from a bag placed inside a pressure infusor or pressurised container is passed via a plastic tube which may be a standard giving set to a Luer lock on the valve housing. A push button or lever control of the valving arrangement allows the saline to flow under pressure down the operating channel.
Alternatively, irrigating fluid may be substituted by carbon dioxide gas from a low pressure system in the same way, to inflate the bowel with carbon dioxide as an alternative to room air. On top of the valve is a port that allows instruments e.g. injecting needles, snares, biopsy forceps banding equipment or any normal endoscopic instrument to be passed in the usual manner, with the device still attached to the endoscope. This device allows pressurised irrigating fluid to pass down the operating channel of any endoscope to clear away blood/food/faecal residue. It is operated by the endoscopist, and avoids the need for syringes, thus freeing up a member of staff who would otherwise need to fill them for the endoscopist. Furthermore, instruments can be passed down the operating channel of the endoscope without removing the device. Where variceal banding equipment is used, it may be attached with the device in place, and saline can be passed alongside the thread that is passed down the operating channel. This device allows large quantities of fluid to be passed down the endoscope at once, compared to syringes, which can pass no more than 50ml at a time. Instillation of warm water is shown to be a useful and safe method of relieving spasm during colonoscopy, which can easily be done by warming the bag of saline prior to attachment to the device. Instillation of larger volumes of fluid (200 - 1000ml) has been used in some centres to make colonoscopy easier and more comfortable, which is facilitated once again using this device. This device also allows the passage of C02 down the operating channel of the endoscope where it is preferred to room air, to prevent excess wind trapping and discomfort after endoscopic procedures. In Figure 10 is shown a medical device 14, the valve lever 15 which operates on the spring biased seal 16, a non return valve 17 for flow into port I, a plug rectangle 18 to close off the first passageway of the housing moulding, a "fluid in" luer lock 19, the direct access port II to the scope operating channel, an adaptor 20 and the scope operating channel 21. Shown as part of Figure 10 are exploded parts 22 through 25. Numeral 22 shows a seal with adequate seal to prevent excess gas loss around medical device port in irrigation device. Numeral 23 shows an O ring to seal gas. Spring of sufficient strength to keep seal intact. Numeral 24 shows option of a lure lock.
Numeral 25 shows seal with adequate seal to prevent excess gas loss around lure. Material choices include FDA approved PC or PP for the main body, LDPE for the plug rectangle, TPR for the non return valve, LDPE for the seal, LDPE or PP for the lever, LDPE or PP for the top cap, and SS for the spring, and water potable grade of TPR for the adaptor. Any O-ring can be of FDA acceptable O-ring material.
References:
1 : Baumann UA: Water intubation of the sigmoid colon: water instillation speeds up left sided colonoscopy. Endoscopy 1999 May;31(4):314-7
2: Hamamoto N, Nakanislii Y, Morimoto N et al.: A new water instillation method for clonoscopy without sedation as performed by endoscopists-in-training. Gastrointestinal Endoscopy, 2002 Dec;56(6):825-8
3: Church JM: Warm water irrigation for dealing with spasm during colonoscopy: simple, inexpensive, and effective. Gastrointestinal Endoscopy 2002 Nov;56(5):672-4