DISTAL CLOSING CATHETERS AND METHODS FOR SAME
A catheter for insertion into a body cavity of a subject (such as the urinary bladder), and having a drainage tube extending from a drainage opening adjacent a distal end of the catheter to a drainage outlet adjacent a proximal end of the catheter; a closure member mountable for sliding movement within the drainage tube between a first position such that said drainage opening is in fluid communication with the drainage outlet and a second position wherein the closure member blocks fluid communication between the drainage opening and the outlet port; and an actuator, operable from the proximal end of the catheter, to move the closure member between the first and second positions. The closure member can comprise a second tube, sliding within the drainage tube, or a slideable plug.
The invention relates to catheters for draining fluids from body cavities of human or animal subjects and especially for those catheters that can also instil a medicament into the cavity following drainage. The invention is especially concerned with such catheters for draining urine from the urinary bladder of a subject and instilling a medicament therein.
BACKGROUND AND PRIOR ART KNOWN TO THE APPLICANTThere are a number of conditions that require patients to manually drain urine from the bladder at intervals, and this can be performed either under the supervision of an attending physician or healthcare worker, or on occasions can he performed by a patient themselves. One such common condition is an overactive bladder. For many conditions it is also necessary to deliver a medicament to the bladder. For this to be successful, it is important that the bladder is initially drained of any accumulated urine to prevent dilution of the medicament, so allowing a pre-determined dose to be applied. Direct application of medicaments to the interior of the bladder, known as “intravesical” administration is becoming more common, and one such specialised catheter to allow drainage and intravesical administration is described in UK patent GB 2448892. In this device, a urinary cannula is described, and that comprises a number of channels extending from a proximal to a distal end of the catheter. There is a drainage channel to allow urine to flow from one end to the other; and installation channel to allow medicament to be delivered from the proximal to the distal end and a control channel to allow a viscous control fluid to be delivered to a cuff located within the drainage channel. In some embodiments a further channel is provided to allow delivery of a fluid to a balloon adjacent to the external wall of the catheter, known as a Foley balloon, which may be inflated to secure the end of the catheter at the correct position in the bladder after insertion via the urethra.
Such devices are complex and expensive to manufacture, and it is an object of the present invention to provide an improved such catheter.
SUMMARY OF THE INVENTIONAccordingly, the invention provides a catheter for insertion into a body cavity of a subject, comprising: a drainage tube extending from a drainage opening adjacent a distal end of the catheter to a drainage outlet adjacent a proximal end of the catheter; a closure member mountable for sliding movement within said drainage tube between a first position such that said drainage opening is in fluid communication with said drainage outlet and a second position wherein said closure member blocks fluid communication between said drainage opening and said outlet port; and an actuator, operable from the proximal end of the catheter, to move said closure member between said first and second positions. In this way, a simplified device is provided, having a slideable closure member, rather than an internally-mounted inflatable balloon as previously provided on such catheters. This simplifies manufacture, and also simplifies operation, as the valve closure mechanism is less likely to be confused with the other ports often seen on such catheters. This is especially important if the device is to used by the patient themselves.
Preferably, the catheter further comprises an instillation lumen extending from art instillation port adjacent a proximal end of the catheter to an instillation outlet adjacent a distal end of the catheter. More preferably, the catheter further comprises a non-return valve configured to resist flow in said instillation lumen in a direction from the distal end to the proximal end.
In preferable embodiments, said actuator is configured to move said closure member between said first and second positions irreversibly. In this way, re-use of the device is prevented, thereby reducing the risk of cross-infection.
In a first preferable variant, said closure member comprises a plug and said actuator comprises a filament attached to said plug, said filament extending to the proximal end of the catheter.
In a second preferable variant, said closure member comprises a secondary tube located within said drainage tube, said secondary tube having an aperture in its wall such that, in said first position said aperture fluidly communicates with said drainage opening and in said second position said fluid communication is blocked, and wherein said secondary tube extends to the proximal end of said catheter such that it may be manipulated to slideably move said tube between its first and second positions, thereby acting as said actuator.
Preferably, the second variant is configured such that said sliding movement is in an axial direction. More preferably, the cross-sectional profile of said drainage tube and the profile of the outside surface of said secondary tube are so shaped as to resist relative rotational movement therebetween whilst allowing relative axial movement therebetween.
In an alternative arrangement, the second variant is configured such that said sliding movement comprises rotation of said secondary tube relative to said drainage tube. Preferably, a cooperating indent and detent are provided on the outside surface of said secondary tube and the internal wall of said drainage tube configured to allow relative rotational movement between the secondary tube and the drainage tube whilst resisting relative axial movement therebetween.
In any aspect or variant of the invention it is preferred that a lubricating agent is provided between said closure member and the internal wall of said drainage tube to facilitate relative movement therebetween and/or to provide a fluid resistant seal therebetween
In any aspect of the second variant, it is preferred that a ratchet mechanism is provided to ensure irreversible movement of the secondary tube relative to the drainage tube.
In any aspect of either variant, it is also preferred that the catheter further comprises a balloon adjacent an external wall of the catheter near its distal end and proximal of said drainage opening and connected through a balloon control channel to a balloon control port at the proximal end, the balloon being inflatable and deflatable to respectively increase and decrease the local diameter of the catheter to allow reversible anchoring of the catheter within a body cavity.
A closure member in the form of a secondary tube 7 located within the drainage tube 2. The bore of the drainage tube 2 and the outside diameter of the secondary tube 7 are so sized as to provide a relatively snug fit, whilst allowing the secondary tube 7 to slide within the drainage tube 2 along its full length. In this embodiment, the secondary tube 7 is provided with an aperture 8 in its wall that, in a first position as illustrated in
The secondary tube 7 may be slid within the drainage tube to a second position, illustrated in
Also included in this embodiment is an installation lumen 10, located within the wall of the drainage tube 2, that extends from an installation outlet 11 adjacent the distal end 4 of the catheter to an installation port adjacent the proximal end of the catheter (not illustrated).
It will be appreciated that in embodiments of the catheter, multiple drainage openings 3 may be provided around the periphery of the drainage tube, for example two such outlets, to ensure that flow can be maintained even if one outlet becomes blocked. It will be understood that in this situation, corresponding multiple apertures 8 in the secondary tube will also be provided.
It will be appreciated that such a detent and indent mechanism could be arranged to provide a combination of rotational and axial movement by, for example, providing a helically disposed indent 15 that co-operates with a protruding detent 16.
In any embodiment described herein, it is particularly preferred that a fluid such as a light silicone grease be applied between the interior face of the drainage tube and the outer face of the closure member, either when the closure member is a plug 26 or a secondary tube 7. The use of such a fluid serves two purposes: firstly to lubricate the relative sliding movement of the closure member and the drainage tube and, secondly to provide a more water tight seal there between.
In use, the catheter would be initially configured such that there is an open passage between the drainage opening 3 and the drainage outlet port 27. The catheter would be inserted into the body cavity, for example into the urinary bladder via the urethra, until fluid, such as urine, was seen to discharge from the drainage outlet port 27, which could be conveniently connected to a collection bag via, e.g. a catheter tip connector. Once fluid was seen to discharge from the port, this would indicate that the catheter was in a suitable position within e.g. the bladder and, if one were provided, the location balloon 23 could be inflated to secure the catheter in place. It is particularly preferred and envisaged, however, that no such balloon 23 is provided, but that the proximal end of the catheter could merely be taped in to position on an extremity of a patient, for example on the patient's leg to secure the catheter in place whilst the drainage and/or installation of a drug were carried out. To aid such securement, a clip member may be provided into which the proximal end of the catheter can be secured and the clip fastened to the patient either with adhesive tape or some other releasable means.
Once sufficient fluid (e.g. urine) had been drained from the body cavity, the closure member may be actuated to close the flow path between the drainage opening and the drainage outlet. At this stage, if medicament is to be administered, it can be introduced into the body cavity by injection through the installation port 17 at the proximal end of the catheter, to emerge at the installation outlet 11 via the installation lumen 10.
An example of a syringe and connector suitable for the administration of a medicament is illustrated in
The connector comprises two main elements. The first element is an adapter 142 having, at a first end, a tapered recess 143 to receive the syringe outlet 141. The outlet 141 and recess 143 connect via a push fit connection although additional bonding means can be included to provide a more secure connection. The second end of the adapter 142, shown in the end view
The adaptor 142 itself is seated in a one-way valve fitting 146 having at a first end a recess 147 of shape complementary to that of the channels 144 and ribs 145 to provide a secure fitting. The raised ribs 148 within the recess 147 prevent a standard Luer fitting from being inserted. The second end of the valve fitting 146 can be fitted to the installation port 17. The one-way valve fitting 146 includes a spring 149 or other resilient means known in the art to bias the valve 146 to the closed position when no pressure is exerted on the fluid in the syringe 140. The assembled syringe and connector, including the adapter 142 and valve fitting 146 is shown in
Once administration is complete, the locational balloon 23 (if present) may be deflated, and the catheter withdrawn from the body cavity for disposal.
Claims
1. (canceled)
2. A connector assembly configured to connect a syringe to a catheter, the connector assembly comprising:
- an adapter including: a first end having a tapered recess to receive a syringe outlet from the syringe; a second end having a male connector including recessed channels and raised ribs disposed on a surface of the male connector; and wherein the male connector including the recessed channels and raised ribs is a first contoured profile configured for complementary secure fitting with corresponding contoured profiles.
3. The connector assembly of claim 2 comprising a one-way valve fitting having a valve fitting recess, a recess wall of the valve fitting recess having raised ribs and recessed channels as the corresponding contoured profile.
4. The connector assembly of claim 3, wherein the one-way valve fitting is configured for fitted to an instillation port of a catheter.
5. The connector assembly of claim 4 comprising the catheter, and the catheter includes a urinary catheter.
6. A connector assembly configured for coupling a syringe with a catheter, the connector assembly comprising;
- a valve fitting configured for coupling between the syringe and the catheter, the valve fitting includes: a valve, and a recess in communication with the valve, a recess wall of the recess including a first contoured fitting profile, and the adapter configured for coupling with the valve fitting and a syringe outlet of the syringe, the adapter includes: a first end having an adapter recess configured to receive the syringe outlet, and a second end having a second contoured fitting profile complementary to the first contoured fitting profile of the valve fitting, the second end and the second contoured fitting profile configured to securely fit with the recess wall and the first contoured fitting profile.
7. The connector assembly of claim 6, wherein the first and second contoured fitting profiles include one or more ribs or channels, and
- the one or ribs or channels of the first contoured fitting profile are configured to securely fit with one or more channels or ribs, respectively, of the second contoured fitting profile.
8. The connector assembly of claim 6, wherein the first contoured fitting profile includes one or more of first ribs or channels, and the second contoured fitting profile includes one or more of second ribs or channels complementary to the first ribs or channels.
9. The connector assembly of claim 8, wherein the one or more first ribs or channels of the first contoured fitting profile include:
- ribs arranged at opposing positions along the recess wall of the recess, and
- channels arranged at opposing positions along the recess wall of the recess; and the one or more second ribs or channels of the second contoured fitting profile include:
- ribs arranged at opposing positions along the second end, and
- channels arranged at opposing positions along the second end.
10. The connector assembly of claim 6, wherein each of the first and second contoured fitting profiles are non-circular.
11. The connector assembly of claim 6, wherein the first and second contoured fitting profile are configured to permit secure fitting between the valve recess and recess wall of the valve fitting and the second end of the adapter only.
12. The connector assembly of claim 6, wherein the a recess wall of the adapter recess is tapered.
13. The connector assembly of claim 6 comprising the syringe and the catheter.
14. The connector assembly of claim 13, wherein the catheter includes a urinary catheter.
15. The connector assembly of claim 6, wherein the valve includes a one way valve.
16. A method for administering a fluid to the body comprising:
- coupling an adapter with a syringe outlet of a syringe;
- securely fitting the adapter with a catheter including: receiving an end of the adapter within a recess of the catheter having a recess wall, and engaging a first contoured fitting profile of the recess wall with a complementary second contoured fitting profile of the end of the adapter, wherein the first contoured fitting profile is configured to prevent secure fitting with a circular profile; and
- dispensing a liquid from the syringe through the adapter to the catheter according to the engagement between the first and second contoured fitting profiles.
17. The method of claim 16, wherein engaging the first contoured fitting profile with the complementary second contoured fitting profile includes:
- receiving one or more ribs of the end of the adapter within one or more complementary channels of the recess wall of the recess, and
- receiving one or more ribs of the recess wall within one or more complementary channels of the end of the adapter.
18. The method of claim 16, wherein engaging the first contoured fitting profile with the complementary second contoured fitting profile includes receiving a non-circular second contoured fitting profile of the end of that adapter within a complementary non-circular first contoured fitting profile of the recess wall of the recess.
19. The method of claim 16 comprising a valve fitting associated with the catheter, and the valve fitting includes the recess having the recess wall and a one-way valve, and
- dispensing the liquid from the syringe through the adapter to the catheter includes delivering the liquid through the one way valve.
20. The method of claim 16 comprising preventing the secure fitting of a syringe outlet having a circular profile with the catheter.
Type: Application
Filed: Apr 25, 2018
Publication Date: Oct 25, 2018
Inventors: Scott Glickman (Buckinghamshire), Howard Shapland (Mountergate)
Application Number: 15/962,227