WO2022238668A1

WO2022238668A1 - Suction catheter assemblies

Info

Publication number: WO2022238668A1
Application number: PCT/GB2022/000049
Authority: WO
Inventors: Jamie Daniel PERKINS; Steven Mark TUPPER; Steven James Field; Jonathan Mcneill Flint
Original assignee: Smiths Medical International Limited
Priority date: 2021-05-10
Filing date: 2022-05-05
Publication date: 2022-11-17

Abstract

A closed system suction catheter assembly has a suction catheter (1) extensible through a patient end fitting (204) coupled to a tracheal tube. The patient end fitting (204) has a lavage chamber (206) and a rotatable valve member (201) that, in a first position, enables the suction catheter to be extended through the valve member into the tracheal tube. The valve member (201) can be rotated to a second position where it isolates the lavage chamber (206) from the patient end of the fitting (204) so that liquid supplied to the lavage chamber is prevented from flowing to the tracheal tube.

Description

1

SUCTION CATHETER ASSEMBLIES

This invention relates to suction catheter assemblies of the kind including a suction catheter having a lumen for suctioning, a machine end fitting to which the machine end of the suction catheter is attached, a patient end fitting adapted to fit to a coupling at the machine end of a tracheal tube, the patient end of the suction catheter being slidably extensible through the patient end fitting, and a protective, flexible envelope extending around the suction catheter between the machine end fitting and the patient end fitting, the patient end fitting including a lavage chamber into which the patient end of the suction catheter can be withdrawn.

Suction catheter assemblies may be used to remove secretions from within a tracheal tube or the respiratory passages of a patient. They are also used in other applications. Suction catheter assemblies may be of the closed-system kind in which the catheter is enclosed within a flexible envelope. Such assemblies have a manifold at the patient end with a sliding seal through which a suction catheter can be advanced and withdrawn. The flexible envelope is joined at one end to the manifold and encloses the catheter along its length. The other end of the envelope and the catheter are joined with a rear end housing including a suction control valve and a connector. The connector connects the catheter to a suction source and the valve enables the clinician to control the suction applied by the catheter. In some suction catheter assemblies the catheter has two lumens, one being used for suctioning and the other being used to supply irrigating or lavage liquid along the catheter to its patient end to aid in removing secretions from the tracheal tube.

Examples of closed-system suction catheter assemblies are described in US5269768, US5300043, US4569344, US4638539, US4872579, US5167622, US5779687, US5325850, US5490503, US5419769, US5460613, US5349950, GB2394761, GB2400160, US6109259, US6227197, EP801577B, W096/09082, EP1239907B, EP1478424B, US6588427, EP1620148B, US2004/0221852, EP1911482A, EP1795217A, US2007/0282250,

W02007/143502, US2008/0188833, US6227200, US6543451, EP1239909B, US6602219, EP1347798, W002/49680, US6609520, WO/055143, US6805125, US6923184,

US7021313, US7191782, W02004/101045, US7263997, W02004/103448, WOOO/15276, 2

EP637257B, EP1113835B, EP1210957A, EP1237612B, US7152603, EP1267957B, US6978783, US2004/0007236, US2005/0211253, US2005/0211245, US2005/0235987, US7059322, W02004/032817, US2008/0135051, US4836199, US4850350,

US4967743, US5025806, US5083561, US5220916, US5215522, US5255676, US5277177, US5309902, US5333606, US5343857, US5487381, US5513628, US5791337, EP1343552A, WO02/49699, US6612304, EP1322371A, WO02/28463, US6629530, W002/051485, US6769430, EP1330284, WO02/36191, US6886561, W02004/034946, US7188623, W02006/014431, US7341059, W02005/094925, W02006/103233, W02007/030388, W02009/003135, US4838255, US5107829, US5133345, US5642726, US6702789, US7458955, US7273473, US5139018, US4327723, US4515592, US6099519, EP695556B, US5065754, US5730123, US5207220, US5309903, US7086402, US7597686, US7726315, WO 11020985, GB2468946 and WO2019/077292. Closed system! suction catheters are available from various manufacturers including Smiths Medical, Kimberley Clark, Covidien and Viasys.

Closed system suction catheters often have some means for cleaning the catheter when it is withdrawn from the patient so as to reduce the build-up of secretions on the catheter and thereby extend its useful life. This usually involves incorporating a cleaning chamber in the forward, patient end fitting of the assembly with an inlet for cleaning or lavage fluid. The chamber may include some form of valve on the patient side of the lavage inlet so that once the tip of the catheter has been withdrawn into the chamber past the valve lavage fluid introduced to the chamber flows around the tip of the catheter and is then aspirated through the bore of the catheter, suction being continued during this cleaning process. The valve helps reduce the amount of cleaning fluid that leaks out of the cleaning chamber and flows forwardly down the tracheal tube to which the suction catheter assembly is connected. The valves used in such cleaning chambers may include a simple wiper seal, duck-bill or flap valve. Such valves do not require any manual actuation but do not provide a complete seal and do allow some seepage past the valve. Alternatively, the valve could include a rotatable valve member in an outer housing, the valve member being rotatable through 90° and having a transverse passage through it through which the catheter extends when in its open position. After the catheter has been withdrawn rearwardly through the valve member the valve is manually rotated through 90° so that the passage through the 3 valve member is rotated out of alignment with the patient end fitting and the cleaning chamber is isolated from the tracheal tube and patient. Such valves can provide an effective seal but have a problem in that they rely on the user remembering to switch the valve when cleaning is needed. If the user forgets to close the valve a part at least of the lavage fluid will flow out of the cleaning chamber to the patient.

It is an object of the present invention to provide an alternative suction catheter assembly.

According to the present invention there is provided a suction catheter assembly of the above-specified kind, characterised in that the patient end fitting includes an arrangement that can be manually actuated selectively to isolate the lavage chamber from the patient end of the patient end fitting and to enable supply of lavage liquid to the chamber only when the lavage chamber is isolated from the patient end of the patient end fitting.

The arrangement may include a displaceable valve member and a lavage inlet, the valve member being effective in a first position to allow the suction catheter to be slid through the valve member and to isolate the lavage chamber from the lavage inlet, and in a second position fluidly to connect the lavage inlet to the lavage chamber and to isolate the lavage chamber from the patient end of the patient end fitting. The valve member is preferably rotatable about an axis, the valve member including a passage therethrough at right angles to the rotation axis, the valve member being rotatable between a first position where the passage extends longitudinally of the patient end fitting so that the suction catheter can be extended therethrough to a second position where the passage extends at right angles to the first position and blocks passage of the suction catheter, and the valve member including a lavage inlet passage extending from an axial stem by which the valve member is rotatably mounted with the patient end fitting and opening from the valve member into the lavage chamber in the second position of the valve member.

Alternatively, the valve member may be rotatable and include a T-shape passage extending in a plane at right angles to the axis of rotation of the valve member. The T-shape passage preferably has a cross passage extending across a diameter of the valve member and 4 a side passage opening at one end into the cross passage and at its opposite end opening on the outside of the valve member. The patient end fitting may include a side arm extending at right angles to the patient end fitting by which lavage liquid is supplied to the fitting, and the valve member being rotatable between a first position where the cross passage aligns with the side arm and the side passage opens into the lavage chamber and a second position where the side passage is blocked and the cross passage aligns longitudinally in the patient end fitting such that the suction catheter can be extended through the cross passage.

In another aspect the patient end fitting may include a hinged displaceable member having a first part extending within the patient end fitting, the displaceable member being hingedly movable between a first position where its first part extends longitudinally within the patient end fitting and a second position where its first part extends transversely within the patient end fitting, the displaceable member having a second part extending externally of the patient end fitting, and the second part extending over and blocking access to a lavage inlet in the first position and revealing the lavage inlet for connection thereto in the second position.

Examples of suction catheter assemblies according to the present invention will now be described, by way of example, with reference to the accompanying drawings, in which:

Figure 1 is a side elevation view of a suction catheter assembly connected to a tracheal tube;

Figure 2 is an enlarged cross-sectional side elevation view of a valve in the assembly shown in Figure 1;

Figure 3 is a side elevation view of an alternative valve;

Figures 4 and 5 are cross-sectional side elevation views of the valve of Figure

3 in two different positions; and 5

Figures 6 and 7 are cross-sectional side elevations of third form of valve in two different positions.

With reference first to Figure 1 there is shown a first form of closed-system suction catheter assembly including a section catheter 1 attached at its machine end with a machine end fitting or handpiece 2. The suction catheter 1 may be of the single lumen kind with a suction lumen or of the dual-lumen kind, having a suction lumen and an irrigating lumen.

The or each lumen extends along the length of the catheter 1 and opens at both its patient end 12 and its machine end 13. The catheter 1 is enclosed along its length in a flexible, transparent plastics sleeve or envelope 3 through which the catheter can be gripped and manipulated. The sleeve 3 is attached at its machine end with the hand-piece 2 and at its opposite, patient end with the rear, machine end of a patient end fitting or manifold 4. Preferably, there is a slight leak between the sleeve 3 and the handpiece 2 to allow the sleeve to be compressed when the catheter is extended. The manifold 4 has a cross-shape configuration with a patient end port 40 adapted to fit onto a 15mm coupling at the machine end of a tracheal tube 5, two side ports 41 and 42 adapted to be connected with a breathing system, and the machine end port 43 to which the envelope 3 is sealed. The manifold 4 could have other configurations and be of other sizes. The machine end port 43 includes a wiper seal 44 through which the patient end of the catheter 1 can be advanced and retracted, and a lavage or cleaning chamber on the patient side of the wiper seal. As so far described the assembly is conventional.

I

The assembly differs from previous assemblies by the provision of an arrangement 400 that can be manually actuated selectively to isolate the lavage chamber from the patient end 40 of the patient end fitting 4 (and hence to isolate it from the tracheal tube 5). This enables lavage liquid to be supplied to the lavage chamber only when the lavage chamber is isolated from the patient end 40 of the patient end fitting 4. This arrangement 400 is only shown schematically in Figure 1.

There are several ways in which this can be achieved. Figure 2 shows an arrangement in which the patient end fitting 204 includes a valve 200 having a generally cylindrical valve member 201 having a cylindrical body 202 extending transversely of the housing 203 of the 6 patient end fitting 204 and journaled at opposite ends in mounting holes in the housing so that it is rotatable about an axis at right angles to the axis of the housing. The body 202 of the valve member includes a circular passage 205 extending through it at right angles to the axis of the valve member. The diameter of the passage 205 is sufficient to receive the suction catheter 1 but, in the position shown in Figure 2, the valve member 201 is oriented such that the passage extends transversely of the patient end fitting 204. The patient end fitting 204 includes a lavage chamber 206 on the machine side of the valve member 201 between this and a wiper seal 244. In this position of the valve 201 the lavage chamber 206 is isolated from the patient end of the fitting 204 and the suction catheter 1 cannot be extended out of the fitting. At one end, the valve member 201 projects outwardly of the housing 203 and is terminated by an enlarged knob or lever 207 by which the valve member can be rotated about its axis. At its opposite end the valve member 201 has a reduced diameter stem 208 projecting a short distance through the opposite side of the housing 203. The stem 208 has a fluid passage 209 extending axially through it and through the valve member 201 and is bent transversely of the axis of the valve member so that it opens, in the position shown in Figure 2, through a side opening 210 of the valve member into the lavage chamber 206. At its opposite, outer end, the passage 209 connects with a small-bore lavage tube 211 terminated by a coupling 212 to which a source of lavage liquid can be connected. The tube 211 could be continued through the passage 209 and is preferably flexible.

It can be seen that, if the knob 207 on the valve member 201 is gripped and twisted through 90° clockwise or anticlockwise, the passage 205 will align with the axis of the housing 203 so that the suction catheter 1 can be advanced out of the patient end fitting 204. It will also have the effect of rotating the lavage opening 210 through 90° so that it moves out of alignment with the lavage chamber 206 and instead moves to a position where it is blocked by the wall of the housing. The valve 200 includes stops (not shown) to limit the extent of rotation of the valve member 201 so that the lavage opening 210 on the valve member cannot open into the patient end of the fitting 204. It can be seen that, in this arrangement, that lavage liquid can only be delivered if the lavage opening 210 is oriented to open into the lavage chamber 206 and the lavage chamber is isolated from the patent end of the fitting 204, thereby preventing any risk of lavage liquid flowing into the patient’s 7 respiratory passages. It will be appreciated that other arrangements of the valve 200 could be displaceable through other angles.

Figures 3 to 5 show an alternative patient end fitting 300 with a housing 301 formed with a side arm 302 for supply of lavage liquid and projecting at right angles to the main part of the housing. The valve member consists of a cylindrical drum 303 of circular section inside the housing 301 and extending at right angle to the plane of the fitting and side arm 302. One end of the drum 303 projects through the wall of the housing 301 of the patient end fitting 300 and is terminated by a knob 304 by which the valve member can be rotated about its axis. The drum 303 includes a T-shape passage 306 extending through it with the main limb 307 of the passage extending across the diameter of the drum and a side limb 308 extending at right angles from the midpoint of the main arm to the edge of the drum. Figures 3 and 4 show the valve member 303 oriented with the main limb 307 of the passage 306 aligned axially of the patient end fitting 300 and the side limb 308 extending in the opposite direction away from the side arm 302. In this way, the side limb 308 is blocked by contact with the inside of the patient end fitting 303. In this position, the suction catheter 1 can be extended through the valve member 303 and out of the patient end of the patient end fitting 300 but the valve member blocks flow of lavage liquid through the side arm 302 of the patient end fitting. To enable lavage the suction catheter 1 is pulled rearwardly so that its patient end tip is drawn through the valve member 303 and into the lavage chamber 310 on the machine side of the valve member. The knob 304 of the valve member 303 is then gripped and twisted anticlockwise through 90° to the position shown in Figure 5 where the main limb 307 of the passage 306 through the valve member 303 extends transversely with one end opening into the side, lavage arm 302 so that lavage liquid can flow via this to the side limb 308 that now opens into the lavage chamber 310. In this position of the valve 303 the catheter 1 cannot be extended and the lavage chamber 310 is isolated from the patient end of the fitting 300. The valve arrangement is provided with stops to limit rotation of the valve member 303 between these two positions. The stops are arranged to prevent the valve member 303 being rotated to a position where the lavage arm connects to the patient end of the valve. 8

Figures 6 and 7 show a further patient end fitting 600 with a valve arrangement 601 having lavage inlet 602 and a displaceable member 603 that is effective in a first position to allow the suction catheter 1 to be slid through the valve and to prevent connection to the lavage inlet. In a second position the displaceable member 603 enables connection to the lavage inlet 602 and isolates the lavage chamber 604 from the patient end of the patient end fitting. More particularly, the lavage inlet 602 opens into the lavage chamber 604 on the machine side of the displaceable member, which is in the form of a hinged valve member 603. One end of the valve member 603 is in the form of a disc 605 extending inside the patient end fitting 600 on the patient side of the lavage chamber 604. The opposite end of the valve member 603 is in the form of curved lever or guard 606 projecting externally of the patient end fitting 600.

In the position shown in Figure 6 the valve member 603 is positioned with its internal end 605 extending generally parallel to the axis of the fitting 600 so that the catheter 1 can be moved freely through the fitting. In this position the external endi606 of the valve member

603 extends generally parallel to the fitting 600 in a rear or machine direction along the outside of the fitting and covers or encloses the lavage inlet 602 so that connection cannot be made to this. Lavage liquid cannot, therefore be supplied to the patient end fitting 600 when lavage chamber 604 is open to the patient end of the fitting. When the catheter 1 needs to be cleaned it is pulled rearwardly so that its patient end tip is drawn into the lavage chamber

604 on the machine side of the valve 603. The outer end 606 of the valve member 603 is then gripped and hinged forwardly, towards the patient end, so that the valve member 603 is rotated clockwise through 90°. This rotates the inner part 605 of the valve member 603 down against an annular valve seat 607 around the inside of the patient end fitting 600 and at the same time raises the outer end 606 of the valve member clear of the lavage opening 602. In this position a source of lavage liquid can be connected to the lavage inlet 602 and lavage liquid supplied to the lavage chamber 604.

Claims

9

CLAIMS A suction catheter assembly including a suction catheter (1) having a lumen for suctioning, a machine end fitting (2) to which the machine end of the suction catheter is attached, a patient end fitting (4, 204, 300, 600) adapted to fit to a coupling at the machine end of a tracheal tube, the patient end of the suction catheter (1) being slidably extensible through the patient end fitting (4, 204, 300, 600), and a protective, flexible envelope (3) extending around the suction catheter (1) between the machine end fitting (2) and the patient end fitting (4, 204, 300, 600), the patient end fitting including a lavage chamber (206, 310, 604) into which the patient end of the suction catheter can be withdrawn, characterised in that the patient end fitting (4, 204, 300, 600) includes an arrangement (200, 303, 601) that can be manually actuated selectively to isolate the lavage chamber (206, 310, 604) from the patient end of the patient end fitting and to enable supply of lavage liquid to the chamber only when the lavage chamber is isolated from the patient end of the patient end fitting. An assembly according to Claim 1, characterised in that the arrangement includes a displaceable valve member (201, 303) and a lavage inlet (209, 302), and that the valve member (201, 303) is effective in a first position to allow the suction catheter (1) to be slid through the valve member and to isolate the lavage chamber (206, 310) from the lavage inlet (209, 302), and in a second position; fluidly to connect the lavage inlet (209, 302) to the lavage chamber (206, 310) and to isolate the lavage chamber from the patient end of the patient end fitting (4, 204, 300). An assembly according to Claim 2, characterised in that the valve member (201) is rotatable about an axis, that the valve member includes a passage (205) therethrough at right angles to the rotation axis, that the valve member (201) is rotatable between a first position where the passage (205) extends longitudinally of the patient end fitting (204) so that the suction catheter (1) can be extended therethrough to a second position where the passage (205) extends at right angles to the first position and blocks passage of the suction catheter, and that the valve member includes a lavage inlet passage (209) extending from an axial stem (208) by which the valve member (201) is rotatably mounted with the patient end fitting (204) and opening from the 10 valve member into the lavage chamber (206) in the second position of the valve member. An assembly according to Claim 2, characterised in that the valve member (303) is rotatable and includes a T-shape passage (306) extending in a plane at right angles to the axis of rotation of the valve member (303). An assembly according to Claim 4, characterised in that the T-shape passage (306) has a cross passage (307) extending across a diameter of the valve member (303) and a side passage (308) opening at one end into the cross passage (307) and at its opposite end opening on the outside of the valve member (303). An assembly according to Claim 5, characterised in that the patient end fitting (300) includes a side arm (302) extending at right angles to the patient end fitting (300) by which lavage liquid is supplied to the fitting, and that the valve member (303) is rotatable between a first position where the cross passage (307) aligns with the side arm (302) and the side passage (308) opens into the lavage chamber (310) and a second position where the side passage (308) is blocked and the cross passage (307) aligns longitudinally in the patient end fitting (300) such that the suction catheter (1) can be extended through the cross passage. An assembly according to Claim 1, characterised in that the patient end fitting (600) includes a hinged displaceable member (603) having a first part (605) extending within the patient end fitting (600), that the displaceable member (603) is hingedly movable between a first position where its first part (605) extends longitudinally within the patient end fitting (600) and a second position where its first part (605) extends transversely within the patient end fitting (600), that the displaceable member (603) has a second part (606) extending externally of the patient end fitting (600), and that the second part (606) extends over and blocks access to a lavage inlet (602) in the first position and reveals the lavage inlet for connection thereto in the second position.