URINARY CATHETER

Abstract

There is described a urological device comprising one or more valves within a valve housing, external to the body when in use, with means for connection to an in-dwelling catheter and a means for connection to a urine collection device for the reduction of Catheter Associated Urinary Tract Infections (CAUTI's), the valve characterised by having a higher opening pressure than closing pressure, and the urological device having one or more valves movable from a closed position to an open position in response to applied urological/intra-abdominal pressure; and wherein the device is provided with a vent to prevent siphoning action from the urine collection device; and wherein the valve has a region of coaption and the number of valves is varied to provide opening pressures matched to one or more intra-abdominal pressures in one or more patient groups.

Claims

1. A urological device comprising one or more valves within a valve housing, external to the body when in use, with means for connection to an in-dwelling catheter and a means for connection to a urine collection device for the reduction of Catheter Associated Urinary Tract Infections (CAUTI's), the valve characterised by having a higher opening pressure than closing pressure, and the urological device having one or more valves movable from a closed position to an open position in response to applied urological/intra-abdominal pressure; and wherein the valve has a region of coaption and the type and/or number of valves is varied to provide opening pressures matched to one or more intra-abdominal pressures in one or more patient groups; and wherein said valve housing is provided with a vent.

2. (canceled)

3. A urological device according to claim 1 wherein the vent is provided with a check valve.

4-9. (canceled)

10. A urological device according to claim 1 wherein the valve comprises a resiliently flexible diaphragm valve member.

11. A urological device according to claim 10 wherein the diaphragm valve comprises a resiliently flexible material provided with a slit in its body.

12. (canceled)

13. A urological device according to claim 1 wherein the valve is provided with a rolling sleeve.

14. A urological device according to claim 11 wherein the resiliently flexible diaphragm valve member is cut to provide a plurality of valve leaflets; and wherein the valve leaflets are cut to provide a low rugosity cut surface.

15. A urological device according to claim 14 wherein the valve leaflets are cut by ultrasonic cutting.

16. A urological device according to claim 1 wherein the valve or valve body comprises an antimicrobial material.

17. A urological device according to claim 16 wherein the antimicrobial material comprises a composite of a polymeric material and particles of one or more of (nano)silver, copper and keratin.

18.-28. (canceled)

29. A urinary drainage system comprising a catheter tube comprising a balloon/anchor port and a urinary drainage channel, the urinary drainage channel being provided with one or more valves within a valve housing, with means for connection to an in-dwelling catheter and a means for connection to a urine collection device for the reduction of Catheter Associated Urinary Tract Infections (CAUTI's), the one or more valves being characterised by having a higher opening pressure than closing pressure, and the urological device having one or more valves movable from a closed position to an open position in response to applied urological/intra-abdominal pressure; and wherein the valve has a region of coaption and the type and/or number of valves is varied to provide opening pressures matched to one or more intra-abdominal pressures in one or more patient groups; and wherein said valve housing is provided with a vent.

30. (canceled)

31. A urinary drainage system according to claim 29 wherein the vent is provided with a check valve.

32.-35. (canceled)

36. A urinary drainage system according to claim 29 wherein the valve or valve body comprises an antimicrobial material.

37. A method of urinary catheterisation of a patient, said method comprising the insertion of a urological device through the urinary tract into the bladder of a patient, said urological device comprising one or more valves and valve housing, external to the body when in use, connected to an in-dwelling catheter for the reduction of Catheter Associated Urinary Tract Infections (CAUTI's), the valve characterised by having a higher opening pressure than closing pressure, and the urological device having one or more valves movable from a closed position to an open position in response to applied urological/intra-abdominal pressure, wherein the valve is provided with a plurality of valve leaflets possessing a region of coaption; and wherein the design of the coaption region and the type and/or number of valves is varied to provide opening pressures matched to one or more intra-abdominal pressures in one or more patient groups; and wherein said valve housing is provided with a vent.

38. (canceled)

39. A method according to claim 37 wherein the vent is provided with a check valve.

40.-42. (canceled)

43. A method according to claim 37 wherein the one or more valves comprise a resiliently flexible diaphragm valve member.

44. A urological device according to claim 43 wherein the diaphragm valve comprises a resiliently flexible material provided with a slit in its body.

45-46. (canceled)

47. A method according to claim 44 wherein the resiliently flexible diaphragm valve member is cut to provide a plurality of valve leaflets; and wherein the valve leaflets are cut to provide a low rugosity cut surface.

48. A method according to claim 47 wherein valve leaflets are cut by ultrasonic cutting.

49. A method according to claim 37 wherein the valve or valve body comprises an antimicrobial material.

50. A method according to claim 49 wherein the antimicrobial material comprises a composite of a polymeric material and particles of one or more of (nano)silver, copper and keratin.

51.-57. (canceled)

Description

[0049] An embodiment of the invention will now be described with reference to the accompanying drawings in which:

[0050] FIGS. 1(a) to (c) are cross-sectional views of a urological device valve assembly;

[0051] FIGS. 2(a) to (c) are cross-sectional views of a urological device valve assembly provided with a valve chamber;

[0052] FIG. 3 a perspective view of a urological device kit;

[0053] FIG. 4(a) is an enlarged, cross-sectional view of the, with the valve shown in a fully closed and partially extended position;

[0054] FIG. 4(b) is an enlarged, cross-sectional view of the valve, with the valve shown in a fully closed and fully extended position, wherein a valve head portion of which is shown beginning to snap outwardly; and

[0055] FIG. 4(c) is an enlarged, cross-sectional view of the valve shown in a fully open, and fully extended position, wherein the valve head portion of which is shown snapped fully outwardly;

[0056] FIG. 5 is a frequency plot of abdominal (bladder) pressure by gender; and

[0057] FIG. 6 shows Differential Pressure versus flow for a Sureflo versus an umbrella valve.

[0058] Referring to FIGS. 1(a) to (c), a urological device 1 comprises a catheter 2, wherein a first end 3 is connected to a patient (not shown) and a second end 4 is connected to a fluid inlet nozzle 5 of a valve member 6.

[0059] The valve member 6 comprises a fluid inlet nozzle 5, a valve chamber 7 and a fluid outlet tube 8. A diaphragm valve 9 is located in the valve chamber 7. The valve chamber 7 is provided with a vent 10. The vent is provided with an umbrella valve 11.

[0060] The diaphragm valve 9 comprises a concave valve member 12 consisting of a resiliently flexible material and is provided with a slit 13 (not shown, see FIG. 4) or a pair of slits in its body. It will be appreciated that a variety of slit arrangements may be suitable for the invention to perform satisfactorily.

[0061] Referring to FIGS. 2(a) to (c), a urological device 1 comprises a catheter 2, wherein a first end 3 is connected to a patient (not shown) and a second end 4 is connected to a fluid inlet nozzle 5 of a valve member 6.

[0062] The valve member 6 comprises a fluid inlet nozzle 5, a valve chamber 7 and a fluid outlet tube 8. The valve chamber 7 provides a housing 7(a) for a diaphragm valve 9. The valve chamber 7 is provided with a vent 10. The vent is provided with an umbrella valve 11.

[0063] In the urological device of both FIGS. 1(a) to (c) and FIGS. 2(a) to (c), when the concave valve member 12 is in the closed position fluid is retained behind the concave valve member 12. When the fluid pressure reaches a predetermined level the concave valve member 12 flexes and the slit 13 opens to create an aperture (not shown), allowing fluid to flow through the fluid outlet tube 8, thus relieving the fluid pressure. When the fluid pressure drops below the predetermined level, the slit 13 closes again and the valve is shut. This is shown more clearly in FIG. 4.

[0064] Referring to FIG. 3, a urological device kit 14 comprises a group of three urological device valve assemblies. Although it will be understood that in the kit of the invention the number of urological device valve assemblies may be varied, the present invention particularly provides a kit comprising urological device valve assemblies, e.g. provided with a selection of valves of about 40 cm H.sub.2O, 50 cm H.sub.2O and 55 cm H.sub.2O opening pressure, which is found to be suitable for use with the majority of patients.

[0065] Referring to FIGS. 4(a) to (c), in operation, the valve functions in the following manner: When fluid pressure imparts with the valve 6, as illustrated in FIG. 4(a), valve head 14 shifts axially outwardly by rolling connector sleeve 15 over upon itself. Valve head 14 continues to extend outwardly toward the exterior of valve seat 16 until connector sleeve 15 is fully extended.

[0066] As illustrated in FIG. 4(b), valve head 14 continues to shift outwardly. However, since connector sleeve 15 is fully extended, further outward shifting of valve head 14 longitudinally tenses or stretches connector sleeve 15, thereby increasing the outward force applied to the valve head 14. Further outward movement of valve head 14 tends to flatten or straighten valve head 14, particularly along exterior surface 17, as illustrated in FIG. 4(b). This flattening motion dilates the circular configuration of valve head 14.

[0067] When connector sleeve 15 is in the fully extended position; and additional pressure is imparted on the valve 6, exterior rim 18 moves axially and radially outwardly.

[0068] The snap type opening of valve 6 is achieved, by the force exerted by connector sleeve 15, which is sufficient to substantially distort the shape of valve head 14. When valve 6 assumes the fully extended and fully open position illustrated in FIG. 4(c), valve flaps 19 of valve head 14 are bent or elastically deformed outwardly. Valve flaps 19 tend to fold openly and the continued radial inward compression applied to valve head 14 by connector sleeve 15 and the outwardly oriented torque applied thereto by connector sleeve 15 combine to keep valve 6 in the fully open position, even if the pressure imparted on valve 6 is reduced.

[0069] Hence, after valve 6 has been opened through the application of fluid pressure, that pressure which is required to maintain fluid flow through valve 6 is reduced, or less than the threshold pressure, so as to provide greater ease of flow control.

[0070] The resiliency of connector sleeve 15 serves to resist the dilating action of valve head 14 and therefore if the resiliency of connector sleeve 15 is varied, for example, by making connector sleeve 15 thicker or thinner, the amount or degree of snap action can be adjusted for any specific patient requirements.

[0071] When pressure is reduced, valve 6 will still remain open in substantially the fully open position shown in FIG. 4(c), until the pressure reaches the preselected closure pressure, at which point, the forces developed in connector sleeve 15 through elastic deformation from its original moulded shape, pulls valve head 14 inwardly, back into a concave orientation, thereby securely valve 6 with a snapping action.

[0072] This snap closing motion of valve head 14 serves to close valve 6 very quickly and very completely, so as to sharply cut off the stream of fluid being discharged without any drops or dribbles. Valve 6 will continue to assume the fully closed, until such time as the pressure is further reduced, due to the vent (not shown) to permit the resiliency in connector sleeve 15 to urge valve head 14 back into a fully retracted position.

[0073] Referring to FIG. 5, the graph illustrates that the urological pressure varies within patient groups and also varies depending upon gender.

[0074] Referring to FIG. 6, a typical pressure versus flow characteristic is shown for a SureFlo and a generic umbrella valve. Points A, B, C, D in FIG. 5 describe a typical umbrella valve characteristic and A, B, C, D describe a SureFlo valve. For a closed umbrella valve as pressure is increased there is no flow until point A. The valve will open slightly enabling a low flow (dripping). As pressure is increased, between A and B, the flow also increases with an approximate linear relationship. Once the pressure is decreased, between B to C, hysteresis is observed.

EXAMPLE 1

[0075] In vitro Valve Tests

[0076] Bristol Urological Institute carried out in vitro tests upon valves. The valve is able to open and close reliably for up to 14 days and prevented the migration of a highly motile bacterium, Proteus mirabilis up through the drainage system. The bladder of control models (without the valve) became infected with Pr. mirabilis between 144 and 168 hours but the bladders of the valved models remained sterile. This pilot works demonstrates that the more natural filling and emptying cycle that the valve provides reduces the risk of infection through the intraluminal route in the drainage system when compared with the normal continual drainage that happens with an indwelling catheter.

EXAMPLE 2

[0077] Urinary Catheter Fill and Flush (FF) Valve Trial

[0078] Human Trials

[0079] Urinary Catheter Fill and Flush Valve: Safety, Effectiveness, Acceptability and Feasibility Trial, Protocol Version 2.3 Dated Jul. 4, 2016 Developed and to be conducted by Prof. M. Fader, University of Southampton.

[0080] Aims

[0081] To assess the safety, effectiveness, comfort and acceptability of the valve on acute care and community-dwelling participants with a short or long term urinary catheter.

[0082] Objective

[0083] Determine if the process of filling and automatic draining is comfortable and acceptable for participants, if the valve opens automatically for bladder emptying (<100 ml remains) during daily activities and rest.

[0084] PPI (Patient and Public Involvement) Study Management

[0085] Steering group of relevant patients, carers and clinicians will support this work by, for example, providing comment on study documentation and advising on refinement of recruitment strategy.

[0086] Outcomes

[0087] Reliable valve opening, bladder emptying, comfort, acceptability, Quality of Life

[0088] Setting

[0089] Clinical Research Facilitydedicated research area at Southampton General Hospital.

[0090] Participants

[0091] 16 of each long and short-term indwelling catheter (LTIC) users over 18 years (8 who currently use a standard manual valve (e.g. a flip-flo) and 8 who use a leg bag. Eligibility and Exclusion criteria will be applied.

[0092] Data Collection

[0093] Demographic, Quality of Life, Number and frequency of openings, Recumbent and resting, residual bio-burden.

[0094] Valve Questionnaire

[0095] Participants will assess the valve for comfort, discreetness, appearance, ease of use and effectiveness (including any leakage).

[0096] Randomisation

[0097] Participants will be randomised to a Study Arm using block randomisation, indicated by a letter in a sealed envelope, with 10 participants in each Study Arm.

[0098] Microbiological Analysis

[0099] Will be carried out on urine samples taken at the start and end of the study period, and on catheters following removal using culture onto selective agar. For catheter samples, biofilm formation will be analysed by EDIC Microscopy and indirect methods using resuspension and viability stains.

[0100] Transcripts Analysis

[0101] Will include constant comparison aided by NVivo software, iteratively rearranged as themes develop, variations are highlighted and divergent or contradictory cases explored.

[0102] Testing Procedure [0103] 1. Bladder scan and record volume in Valve Log [0104] 2. Fit the lowest pressure valve and attach a leg bag for urine collection [0105] 3. Bladder scan and record volume in Valve Log [0106] 4. When not being scanned, the participant will be asked to sit in a chair, only standing to transfer between bed and chair. [0107] 5. Ask the participant to drink a minimum of 500 ml of fluids over first two hours, 150 ml per hour until 6 hours and freely thereafter. [0108] 6. If the valve is remaining open and urine is draining freely, replace with the next level pressure valve (up to 3 valves) until free drainage has ceased. [0109] 7. Record participant's bladder sensations before each scan using Valve Log. [0110] 8. With the participant lying down, scan bladder every hour (record time and volume in Valve Log) until volume is >400 ml or the participant experiences bladder discomfort or the valve automatically opens. [0111] a. If the valve automatically opens: [0112] i. Record the amount of urine voided [0113] ii. Scan the bladder for any residual volume [0114] b. If the volume is >400 ml or the participant is experiencing discomfort [0115] i. Ask the participant to contract abdominal muscles to increase bladder pressure or bear down as if trying to pass urine. [0116] ii. If the valve opens, proceed as above (a). [0117] iii. If the valve does not open, disconnect the valve, re-attached the leg bag and allow the bladder to drain. [0118] 9. If the valve has opened with a urine volume of less than 500 ml, repeat process 7 & 8 at 1 hourly intervals for 8 hours. If valve did not open at less than 500 ml, stop testing.