GB2488148A

GB2488148A - Insufflation Apparatus

Info

Publication number: GB2488148A
Application number: GB201102786A
Authority: GB
Inventors: Ravi Bickram K Shrestha; Dylan Griffiths
Original assignee: MEDICSIGHT UK Ltd
Current assignee: MEDICSIGHT UK Ltd
Priority date: 2011-02-17
Filing date: 2011-02-17
Publication date: 2012-08-22
Also published as: GB201102786D0

Abstract

The apparatus comprises a catheter 9, an insufflator 1, and a connector 11 with a first port 16 connected to the insufflator, a second port 17 connected to the catheter 9, and a third port (18) connected to an effluent reservoir 7. The ports being interconnected such that insufflating gas passes from the first port to the second port and effluent flows from the second port to the third port and thence into the reservoir 7. The first and second ports may be mutually offset, or a baffle (20, Fig 5a) may be provided between the first and second ports to reduce the risk of effluent passing into the first port from the second port. A barrier 12 which may be a hydrophobic filter is provided to prevent effluent from passing through the first port towards the insufflator while allowing insufflating gas to pass through the first port. The reservoir 7 may be connected directly to the third port 18 as a unitary component.

Description

Insufflation Apparatus and Component

Field of the Invention

[00011 The present invention relates to an insufflation apparatus, a component thereof and a method of manufacture of the component, the component being particularly but not exclusively for collecting effluent and/or preventing effluent from reaching an insufflator.

Background of the Invention

[00021 Insufflation is a medical or diagnostic procedure in which an inert gas, such as carbon dioxide, is used to distend a body cavity or lumen. Applications include laparoscopy and colonoscopy. In virtual colonoscopy, insufflation is used to distend the colon, from which a 2D or 3D computed tomography (CT) scan is then taken.

[00031 Conventional colonic insufflation apparatus comprises: a catheter for introduction into the colon; an insufflator for passing insufflating gas into the catheter at a controlled pressure; and a filter connected between the catheter and the insufflator, for preventing effluent from the colon from reaching the insufflator. Examples of such apparatus are disclosed in patent publications EP-A-1 101506 and WO-A-00/6951 1.

[00041 Patent publication WO-A-03/045303 discloses insufflation apparatus including a reservoir for collecting effluent so as to prevent contamination of other components of the apparatus. The reservoir is connected in-line between the insufflator and the catheter, so that insufflating gas passes through the reservoir before reaching the catheter, and effluent flows from the catheter into the reservoir. One problem with this arrangement is that the effluent, once collected, may block or impede the insufflating gas. Another problem is that the reservoir, which is preferably a flexible bag, forms part of the structural connection between the insufflator and the catheter. Hence, any tension in the tubes connected between the reservoir and the catheter, and between the reservoir and the insufflator, will be applied across the reservoir. In extreme cases, this could cause the effluent reservoir to rupture.

100051 Other insufflation apparatus, marketed by Vimap Technologies of Girona, Spain under product numbers AS-Y-L-R3SB and AS-Y-L-R5OB, have separate connections from the catheter to the insufflator and to the reservoir. However, effluent may flow through the connection to the insufflator, so that a further barrier is required to protect the insufflator.

Also, this arrangement requires a three-way catheter connector, which is more expensive than a conventional two-way connector.

Statement of the Invention

[0006] According to one aspect of the present invention, there is provided an insufflation apparatus, comprising a catheter, an insufflator, and a connector connected therebetween.

The connector has a first port connected to the insufflator, a second port connected to the catheter, and a third port connected to a reservoir, the ports being interconnected such that insufflating gas passes from the first port to the second port, and effluent flows from the second port to the third port and thence into the reservoir.

[00071 The first and second port may be mutually offset. Alternatively or additionally, a baffle may be provided between the first and second ports. Advantageously, either or both arrangements reduce the risk of effluent passing into the first port from the second port.

[00081 A gas-permeable barrier may be provided between the first port on the one hand, and the second and third ports on the other hand. The barrier may comprise a filter. The barrier may substantially prevent effluent from passing through the first port towards the insufflator, while allowing insufflating gas to pass from the insufflator through the first port.

[0009] The reservoir may be connected directly to the third port, and may be provided as a unitary component with the connector. This integrated component is considered to be independently inventive.

[0010] The third port may include a first passage for the flow of effluent into the reservoir, and a second passage for venting or pressure equalisation between the reservoir and the connector. The first passage may open in a lower part of the connector, so as to collect effluent when in use, while the second passage may open in an upper part of the connector, so as to avoid collecting effluent.

[0011] The feature of offset ports with a filter therebetween is also considered to be independently inventive, and according to a third aspect of the present invention, there is provided a filter component for use with an insufflating apparatus, the filter component having a first port for connection to an insufflator and a second port for connection to a catheter, the first and second ports being mutually offset, with a filter provided therebetween.

[0012] The feature of a separate venting or pressure equalisation passage is considered to be independently inventive and thus according to a third aspect of the invention there is provided a reservoir for an insufflation apparatus, the reservoir having a first passage for admitting effluent into the reservoir and a second passage for venting the interior of the reservoir, the first and second passages passing through a single opening in the reservoir.

Brief Description of the Drawings

[0013] Specific embodiments of the invention will now be described, purely by way of example, with reference to the accompanying drawings identified below.

Figure 1 is a schematic diagram of insufflation apparatus according to a first S embodiment of the invention.

Figure 2a is a perspective view of part of an insufflation apparatus according to a second embodiment.

Figure 2b is a cross-section through part of the insufflation apparatus of the second embodiment.

Figures 3a and 3b are respectively side and perspective views of a filter housing according to a third embodiment of the invention.

Figure 4 is a schematic diagram of insufflation apparatus according to a fourth embodiment of the invention.

Figures 5a, Sb and Sc are respectively perspective, side and bottom views of a filter housing in the fourth embodiment.

Figures 6a and 6b are perspective views of patient side and insufflator side parts of the filter housing of the fourth embodiment.

Figure 7 is an exploded view of the filter housing, filter and reservoir of the fourth embodiment.

Detailed Description of Embodiments

[00141 In the following description, functionally similar parts carry the same reference numerals. References to the orientation of certain components, such as upper', lower', bottom', top' and the like, are with reference to the normal orientation of those components in use, although there may be features of those components which allow their normal orientation to be determined even when those components are considered in isolation.

First Embodiment [00151 As shown in Figure 1, insufflation apparatus according to a first embodiment comprises the following principal components: a. an insufflator 1, which may be of conventional form, for supplying insufflating gas such as CO2 at the required pressure for insufflation. The insufflator 1 may include a supply of insufflating gas under pressure, or may be connected to a separate said supply. The insufflator 1 preferably includes a regulator, such as a valve, for regulating the pressure at which the gas is supplied. The insufflator 1 may have a user interface allowing control of the supply of insufflating gas. The insufflator 1 may have a connector for removable connection to a proximal end of a first conduit 2, comprising for example a flexible transparent tube.

b. a filter housing 3 connected between the distal end of the first conduit 2 and a proximal end of a second conduit 4. The filter housing 3 contains a filter, such as filter paper. The filter acts as a barrier for preventing effluent from the patient passing into the insufflator 1.

c. a three-way connector 5, such as a T-shapcd or Y-shaped connector, connecting a distal end of the second conduit 4 to a proximal end of a third conduit 6 and a proximal end of a fourth conduit 8.

d. a catheter 9 connected to the distal end of the fourth conduit 8, for introduction into the colon of the patient. The catheter 9 is preferably a single channel catheter, having a single flow path of insufflating gas into the patient and effluent out of the patient. Preferably, an inflatable cuff 10 is provided close to the distal end of the catheter 9. The cuff 10 is inflated after introduction into the colon, for retention of the catheter 9. The catheter 9 carries a separate channel for connection of the cuff 9 to inflating means, such as a syringe (not shown).

e. a reservoir 7, connected to the distal end of the third conduit 6, for collection of effluent flowing from the colon and through the fourth conduit 8 and into the connector 5.

[00161 The above arrangement may be modified without materially affecting its topology.

For example:

a. the filter housing 3 could be connected directly to the insufflator 1, so that the first conduit is not required; b. the connector 5 may be integrated with the second conduit 4, the third conduit 6 and/or the fourth conduit 8, so that a separate connector 5 is not required; c. the connector 5 may be connected directly to the reservoir 7, 50 that the third conduit 6 is not required.

d. The connector 5 may be connected directly to or integrated with the catheter 9, so that the fourth conduit 8 is not required.

[0017] Connections between the conduits 2, 4, 6 and 8 and the other components may be made by integrated or separate connectors, such as push fit connectors, barbed connectors, S Luer locks, Colder locks, sealed connectors and the like.

[0018] The conduits 2, 4, 6 and/or 8 may comprise flexible tubing, made for example of PVC of a diameter in thc rangc 3-10 111111.

[00191 The connector 5, third conduit 6 and/or reservoir 7 may include venting means for equalizing pressure so as to allow effluent to pass into the reservoir 7.

[0020] The reservoir 7 comprises a container of a capacity suitable for collecting the maximum volume of effluent likely to be produced in the procedure for which the apparatus is designed. The capacity may for example be between 50 and SOOml. The reservoir 7 preferably comprises a flexible bag of fluid impermeable material.

[0021] The filter may comprise a hydrophobic filter, so as to avoid damage to the filter if contacted by effluent. The hydrophobic filter may be an antiviral and/or antibacterial filter.

The filter may comprise a membrane of small pore size, preferably in the range 0.1 to 1.0 micron. The membrane may be a PTFE membrane.

[0022] A method of use of the apparatus of the first embodiment will now be described.

However, the method may be applied in a similar fashion to the other embodiments.

a. The apparatus is assembled as described above. Typically, the filter housing 3 and all components downstream in the direction of insufflating gas are disposable and designed for single use, since they may be contaminated by effluent. However, the insufflator 1 is reused for multiple insufflation operations, and may be a comparatively complex and expensive piece of medical equipment.

b. The catheter 9 is introduced into the colon of the patient, with the cuff 10 deflated.

c. The cuff 10 is inflated using the inflating means described above.

d. The insufflator 1 is activated so that insufflating gas flows into the colon, distending the colon and maintaining the colon in its distended state.

e. The required medical or diagnostic procedure is carried out on the colon.

£ The insufflator is deactivated and insufflating gas is allowed to escape from the colon.

g. The cuff 10 is deflated and the catheter 9 removed.

[00231 During any of steps d tof above, effluent from the colon may pass into tile catheter 9 and flow back through the insufflating apparatus, towards the insufflator 1. Since the colon is usually cleansed before insufflation, the effluent typically comprises small quantities of liquid and/or particles of stool. The effluent passes down the fourth conduit 8 and into the connector 5, from which the effluent tends to flow into the reservoir 7 under gravity, since the reservoir 7 and its associated connections such as the third conduit 6 tend to hang downwards. The connector 5 may include a deflector or baffle that directs the flow of effluent towards the reservoir 7, without significantly impeding the flow of insufflating gas through the connector 5. Hence, the connector S directs effluent into the reservoir 7 while reducing the risk of blockage of the flow of insufflating gas. Additionally, the connector S may provide a secure connection between the filter housing 3 and the catheter 9. If the connector 5 becomes detached, for example due to tension in the first, second and fourth conduits 2, 4 and 8, then effluent may still be substantially contained within the reservoir 7.

Second Embodiment [0024] Figures 2a and 2b illustrate a second embodiment of the invention, which differs from the first embodiment in that the filter housing 3 and connector S of the first embodiment are integrated to form a single component, referred to herein as a filter connector 11. For example, the filter housing of the first embodiment may be modified to include an additional connector for the third conduit 6 and/or the reservoir 7. Alternatively, the connector S of the first embodiment may include a filter, such that a separate filter housing 3 is no longer required.

[0025] As shown in Figures 2a and 2b, the filter connector 11 is connected directly to the insufflator 1 through a first port 13, to the fourth conduit 8 through a second port 14 and to the third conduit 6 through a third port 15. Since the reservoir 7 is therefore close to the insufflator 1, the reservoir 7 can be conveniently mounted on a table 16 which carries the insufflator 1.

[0026] Although not shown in Figures 2a and 2b, the distal end of the fourth conduit 8 is connected to the catheter 9, as in the first embodiment.

[0027] As best shown in Figure 2b, filter 12 is secured within the filter connector 11, over the first port 13. The filter 12 prevents effluent from reaching the insufflator 1, and instead the effluent falls through the third port 15 and the third conduit 6 into the reservoir 7.

[0028] Insufflating gas passes from the insufflator 1, through the filter 12, and out of the second port 14, substantially unimpeded by effluent.

Third Embodiment [0029] Figures 3a and 3b show a modification of the filter housing 3 of the first embodiment, in which the ports of the filter housing are mutually offset. A first filter port 16 is arranged in an upper or central part of the filter housing 3, while a second filter port 17 is arranged at a lower portion of the filter housing 3.The first filter port 16 may be connected to the first conduit 2, and the second filter port 17 may be connected to the second conduit 4, as in the first embodiment, such that insufflating gas flows in the direction shown by the arrows in Figure 3a.

[00301 A filter 12 is provided at, in or around the first filter port 16. Preferably, the filter 12 does not extend opposite the second filter port 17. Thus, any effluent that does reach the filter housing will preferably not contact the filter 12, but will collect in the bottom of the filter housing 3. Thus, the risk is reduced of the filter 12 becoming weakened or damaged by contacting the effluent.

Fourth Embodiment [0031] A fourth embodiment, as illustrated in Figures 4 to 7, combines the offset filter housing ports of the third embodiment with the filter connector of the second embodiment, to provide a filter connector 11 with offset ports 16, 17.

[00321 The design of the filter connector 11, as shown in Figures Sa to Sc, is similar to that of the filter housing 3 of the third embodiment, except that a third port 18 is provided at the lower end of the filter connector, for connection to the reservoir 7. In this embodiment, the reservoir 7 is attached directly to the third port 18 during manufacture, for example by heat sealing. The reservoir 7 may take the form of a flexible bag having an opening which is sealed around the third port 18.

[0033] The third port 18 may be subdivided into two passages: a first passage 1 8a communicating directly with the bottom of the internal space of the filter connector 11, and a second passage 1 8b which opens above the bottom of the internal space of the filter connector 11, preferably towards the first port 16 and at or around the lower part of the filter 12. An internal partition 19 within the filter connector 11 forms the upper part of the second passage 1 8b. The second passage 1 8b creates a vent allowing pressure within the reservoir to equalize with the pressure in the remainder of the apparatus, thus allowing effluent to drain easily into the reservoir 7.

[0034] A baffle 20 may be provided above the second port 17, to inhibit migration of effluent towards the filter 12.

[00351 The filter connector 11 may be manufactured in two parts: a patient side 1 la shown in Figure 6a, and an insufflator side 1 ib, shown in Figure 6b. Each part may be formed separately, for example by moulding, before being attached together to form the filter connector 11.

[00361 The insufflator side 1 lb includes a filter support 21, which supports the filter 12 while allowing gas to flow through the majority of the area of the filter 12. As shown in Figure 7, the filter 12 is retained between the filter support 21 and a retaining ring 22, which is attached to the insufflator side 1 lb during manufacture, before assembly to the patient side lla.

[00371 The reservoir 7 is then scaled to the third port 18, for example by heat scaling.

Hence, the filter connector 11 and the reservoir 7 may be provided as an integrated component for connection between a conventional insufflator 1 and a conventional catheter 9. This integrated component may be disposable, and hence need not be designed for re-usc.

Alternative Embodiments [0038] The above embodiments are described with reference to insufflation of the colon, but may be applied with suitable modification to other types of lumen, such as the uterus, stomach or intestines. Embodiments of the invention may be applied to surgical procedures, such as laparoscopy or endoscopy, in which case an insertable hollow needle, such as a Verress needle, may be used in place of a catheter.

[00391 The embodiments described above are illustrative of rather than limiting to the present invention. Alternative embodiments apparent on reading the above description may nevertheless fall within the scope of the invention.

Claims

Claims 1. A barrier and connector component (5; 11) for use in insufflation apparatus, the component comprising: a. a first port (13; 16) for connection to, or connected to an insufflator side of S the apparatus; b. a second port (14; 17) for connection to, or connected to a patient side of the apparatus; c. a third port (15; 18) for connection to, or connected to an effluent reservoir (7); and d. a barrier (12) arranged to prevent effluent entering the second port (14; 17) from exiting the first port (13; 16), and to allow insufflating gas entering the first port (13; 16) to exit the second port (14; 17); wherein the third port (15; 18) is connected to the second port (14; 17) so as to allow effluent entering the second port (14; 17) to exit the third port (15; 18).
2. The component of claim 1, wherein the first port (13; 16) and the second port (14; 17) are mutually offset.
3. The component of claim 2, wherein the second port (14; 17) is offset towards the third port (15; 18).
4. The component of any preceding claim, including the effluent reservoir (7), connected directly to the third port (15; 18).
5. The component of claim 4, wherein the effluent reservoir (7) is permanently sealed to the third port (18).
6. The component of any preceding claim, wherein the third port (18) comprises a first passage (1 8a) for conveying effluent to the reservoir (7), and a second passage (1 8b) for venting or pressure equalisation of the reservoir (7).
7. The component of claim 6, wherein the first and second passages (1 8a, 1 8b) open at different locations within the component, so as to avoid effluent entering the second passage (18b).
8. The component of any preceding claim, including a deflector or baffle (20) for inhibiting effluent from reaching the barrier (12).
9. The component of any preceding claim, wherein the barrier (12) comprises a gas-permeable filter.
10. The component of claim 9, wherein the filter is hydrophobic.
11. A method of manufacturing the component of any preceding claim, comprising sealing the effluent reservoir (7) to the third port (18).
12. A method of manufacturing the component of any one of claims I to 10, comprising forming a first part (1 ib) comprising the first port (13; 16) and a second part (1 la) comprising the second port (14; 17), and joining the first and second parts (ha, lib) together, with the barrier (12) arranged within the component.
13. The method of claim 12, wherein the barrier (12) is retained on the first part (1 ib) prior to joining the first and second parts (11 a, 1 ib).
14. A barrier component for use in insufflation apparatus, the component comprising: a. a first port (13; 16) for connection at an insufflator side of the apparatus; b. a second port (14; 17) for connection at a patient side of the apparatus; and c. a barrier (12) arranged to prevent effluent entering the second port (14; 17) from exiting the first port (13; 16), and to allow insufflating gas entering the first port (13; 16) to exit the second port (14; 17); wherein the first port (13; 16) and the second port (14; 17) are mutually offset so as to deter effluent from contacting the barrier (12).
15. The component of claim 14, including a baffle (20) or deflector arranged to deter effluent from contacting the barrier (12).
16. An insufflation kit comprising the component of any one of claims ito 10, 14 or 15, and a catheter (9) connected to said second port (14; 17).
17. Insufflation apparatus comprising the component of any one of claims i to 10, 14 or is, having an insufflator (1) connected to said first port (13; 16).
18. Insufflation apparatus, comprising a connector (5; ii) having a first port (13; 16) connectable or connected to an insufflator (i), a second port (14; 17) connectable or connected to a catheter (9), and a third port (15; 18) connectable or connected to an effluent reservoir (7); wherein the second port (14; 17) is connectable or connected to the catheter (9) through an intermediate conduit (8).
19. Apparatus of claim 18, wherein the connector (5; 11) includes means for preventing effluent entering the second port (14; 17) from exiting the first port (13; 16).
20. Apparatus of claim 18 or 19, wherein the catheter (9) has a single channel for passage of insufflation gas into the patient and of effluent out of the patient.
21. An insufflation method using the component of any one of claims 1 to 10, the method comprising: a. introducing the catheter (9) into a body cavity or lumen of the patient, with the catheter (9) being connected to the insufflator (1) via said component (5; 11); and b. insufflating the body cavity or lumen through said catheter (9).
22. The method of claim 21, further including collecting effluent from the body cavity or lumen in said effluent reservoir (7), connected to the third port (15; 18).
23. An insufflation method using the barrier component of claims 14 or 15, the method comprising: a. introducing the catheter (9) into a body cavity or lumen of the patient, with the catheter (9) being connected to the insufflator (1) via said connector (5; 11); and b. insufflating the body cavity or lumen through said catheter (9).
24. An insufflation method using the apparatus of any one of claims 18 to 20, the method comprising: a. introducing the catheter (9) into a body cavity or lumen of the patient, with the catheter (9) being connected to the insufflator (1) via said connector (5; 11); and b. insufflating the body cavity or lumen through said catheter (9).
25. Insufflation apparatus substantially as herein described with reference to any one of the specific embodiments and optionally as shown in the accompanying drawings.
26. An insufflation method substantially as herein described with reference to any one of the specific embodiments and optionally as shown in the accompanying drawings.
27. A method of manufacturing an insufflation component substantially as herein described with reference to any one of the specific embodiments and optionally as shown in the accompanying drawings.