WO2009046170A1

WO2009046170A1 - Sampling port cap for foley urine drainage system

Info

Publication number: WO2009046170A1
Application number: PCT/US2008/078545
Authority: WO
Inventors: Vasu Nishtala
Original assignee: C. R. Bard, Inc.
Priority date: 2007-10-02
Filing date: 2008-10-02
Publication date: 2009-04-09

Abstract

A medical device that covers a catheter sampling port is provided The device includes a cap portion The cap portion covers the catheter sampling port The device also preferably includes an occlusion lever preferably rigidly coupled to the cap portion The device also may include a drainage tube housing that is adapted to fixedly attach to a drainage tube in a urine drainage system When the cap portion is opened and the cap moves in a substantially arcuate path with respect to a pivot point located proximally to the occlusion lever, the occlusion lever is adapted to occlude the drainage tube

Description

SAMPLING PORT CAP FOR FOLEY URINE DRAINAGE SYSTEM

The present application claims piioiity to U S Pi o visional Application No 60/976,940, filed Octobei 2, 2007, the disclosure of which is incoipoiated heiein by reference in its entiiety

[00O1] The present disclosure relates to drainage catheteis More specifically, the disclosure relates to impioving comfoit and facilitating urine sampling when using a urinary tract drainage catheter that employs a sampling port

[0002] The most commonly known urinary tract catheter is the Foley catheter The Foley catheter is a catheter device usually made out of elastomer ic material which is foi uiine drainage and which is installed with its distal end in the bladder of the patient. When the distal end of the catheter has been advanced into the bladder, sterile water may be caused to flow along a lumen from the proximal to the distal end of the catheter This balloon retains the distal end of the catheter in the bladder and allows a second lumen (for drainage) in the catheter shaft, open to the bladder at the distal end of the shaft, to drain urine from the bladder to the proximal end of the catheter

[0003] One known sampling port for a Foley catheter is the EZ-Lok™ Sampling Port, which forms part of certain catheters that are manufactured and sold by C. R Bard of Murray Hill, New Jersey FIG IA shows a known Foley catheter The catheter 10 includes a shaft 11 of latex rubber which defines a balloon inflation lumen 12 and a drainage lumen 13 Drainage lumen 13 extends from a distal drainage port 14 to a drainage bag coupling element 15, referred to herein, in the alternative, for purposes of this disclosure as a funnel. The inflation lumen 12 connects a chamber 20 at the distal end of the catheter, but proximal of the drainage port 14, with an inflation funnel 21 at the proximal end of the device. [0004] Alternative to the inflation funnel shown in FIG. IA, in an embodiment known as a pie-filled Foley catheter (not shown), a bulb pre-filled with sterile water could replace the funnel The sterile water could then be used to inflate the chamber

[0005] In one embodiment of a pie-filled catheter, a plug may be used that prevents watei from flowing fiom the bulb to the balloon when the catheter is stored - i e , before the catheter is deployed in a patient.

[0006] A sampling port is shown at 28 A diainage tube, coupled to the portion of the catheter which engages poit 28, which may be an EZ-Lok™ Sampling Port, is shown at 30

[0007] It should be understood that, for the purposes of this application, the details of the Foley catheter desciibed above that are non-essential to the invention are for background purposes only and should not be interpreted to limit the disclosure

[0008] The sampling port may be adapted to accept either Luer-lock syringes 102, as shown in FIG IB, or adapted to accept slip tip syringes 104, as shown in FIG 1C

[0009] Piior to the sampling of urine using the sampling port, the drainage tube is occluded by kinking the drainage tubing at some minimum distance "downstream" from the sampling port Typically, the drainage tubing is kinked until the urine is visible under the sampling port

[0010] A next step in using the sampling port is to swab the surface 202 with an antiseptic wipe 204, as shown in FIG. 2.

[0011] FIG 3 shows a subsequent step of using the sampling poit Using an aseptic technique, a syringe 304 (of the type shown in FIGs IB and 1C) is positioned in the center of the sampling port 302 Syringe 304 is pressed into the port and twisted to gently gain access to the sampling port 302, as shown in FIG 3

[0012] The urine sample is then aspirated fiom port 402 into syringe 404, as shown in FIG 4, and the syringe is removed from port 402 Thereafter, the diainage tubing is unkinked and the cathetei continues to drain urine as before

[0013] As shown in FIGs 1-4, it can be seen that the sampling port presents a iaised profile which can be uncomfortable for a patient, [0014] It would be desirable to provide systems and methods that inciease the comfoit of use of the sampling port. It would also be desiiable to piovide systems and methods that facilitate mine sampling. It would be yet further desiiable to provide systems and methods that enhance drainage characteristics of a urine drainage apparatus.

SUMMARY OF THE INVENTION

[0015] It is an object of the invention to provide systems and methods that inciease the comfort of use of the EZ-Lok™ Sampling Port or other suitable sampling port While much of the disclosure relates to the use of the EZ-Lok™ Sampling Poit, it should be noted that the systems and methods desciibed heiein apply to any suitable catheter sampling port, or other sampling port

[0016] It is also an object of the invention to piovide systems and methods that facilitate urine sampling It is a yet further object of the invention to provide systems and methods that enhance drainage characteristics of a urine drainage apparatus.

[0017] Systems and methods according to the invention piovide a solution that addi esses patient comfoit as well as facilitates urine sampling and urine drainage characteristics. One embodiment of the invention includes two features: a cap portion that may be flipped open and a swivel pinch mechanism The cap covers the EZ-Lok™ Sampling Poit and provides atraumatic comfort when in contact with the patient leg. When a sample is needed, the cap is flipped open and, optionally in the same action, the pinch mechanism is activated

[0018] When the cap is closed, one embodiment of the invention incoipoiates a vent The vent helps in drainage and clearance of air slugs in the diain tube.

[0019] In an additional embodiment of the invention, a cap according to the invention may be used to selectively occlude a bypass lumen The bypass lumen can be incorporated into a Foley catheter for the purposes of measuring Intra- Abdominal Pressure (IAP). The bypass lumen can be in fluid connection with a pressure transducer line and also in fluid connection with a fluid infusion line [0020] In yet another additional embodiment to a proposed apparatus according to the invention, the cap may incorporate a needle free infusion port. Such an embodiment may facilitate conversion of a two-way Foley catheter to a three- way Poley catheter with infusion capability.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG., IA is a longitudinal diametrical section through a Foley catheter¹ incorporating an EZ-Lok™ Sampling Port.

[0022] FIG. IB is a tip of a conventional Luer-lock syringe.

[002,3] FIG 1C is a tip of a conventional slip tip syringe

[0024] FIG 2 shows a first step in a method of use of an EZ-Lok™ Sampling Port.

[0025] FIG. 3 shows a second step in a method of use of an EZ-Lok™ Sampling Port.

[0026] FIG. 4 shows a third step in a method of use of an EZ-Lok™ Sampling Port.

[0027] FIG. 5 shows a perspective view from underneath and to the side of a sampling port cap according to the disclosure.

[0028] FIG 6 shows a perspective view from above and to the side of a sampling port cap according to the disclosure.

[0029] FIG. 7 shows a side view of a proximal end of a Foley catheter implementing a sampling port and cap according to the disclosure.

[0030] FIG. 8 shows a top view of a proximal end of a Foley catheter implementing a sampling port and cap according to the disclosure.

[00.31] FIG. 9 shows a partially sectional side view of a Foley catheter implementing a sampling port and cap according to the disclosure

[0032] FIG. 10 shows a sectional side view of a Foley catheter implementing a sampling port, bypass lumen and cap according to the disclosure.

[003.3] FIG 11 shows a perspective view of another embodiment of a cap according to the disclosure. [0034] FIG 12 shows a perspective view of a two-piece cap accoiding to the disclosure that incorporates a pinned hinge

[0035] F oi the purposes of illustrating the various aspects of the disclosure, there are shown in the drawings forms that are exemplary, it being understood, however, that the invention is not limited to the precise aπangements and instrumentalities shown

[0036] FIG. 5 shows a perspective view from underneath and to the side of a sampling poit cap accoiding to the invention Cap 500 includes cap portion 502, occlusion level 504, living hinge 506, and diain tube housing 508 configured to at least partially enclose a portion of the drain tube of the catheter described above with respect to FIG IA

[0037] In one embodiment of the disclosure, cap 500 operates in the following fashion When a urine sample is needed, cap portion 502 is flipped open In the same action, the entire top portion, including cap portion 502 and occlusion lever 504, pivots (alternatively referred to herein as swivels) on living hinge 506 (for the purposes of this application, a living hinge is defined as a hinge or flexure bearing with no moving paits — it is generally a thin section of the material that bends to allow movement) at the point indicated by the lead line from element number 506, and occlusion lever is forced downward (though the notch for living hinge 506 may be implemented at any suitable point, nevertheless, in certain embodiments, living hinge may be implemented without a notch as well) Thereafter, seπations (which may not be required but may enhance the operation of the occlusion lever) on occlusion level 504, which are shown at the bottom of lever 504, preferably grab the drainage tube (see FIGs 7 and 9) and occlude the drainage tube (not shown in FIG 5)

[0038] FIG 6 shows a perspective view from above and to the side of a sampling port cap 600 according to the disclosure Cap 600 includes cap portion 602, occlusion lever 604, living hinge 606, drain tube housing 608 and vent 610 The vent (alternatively referred to herein as a vent patch) also provides the benefit of allowing air into the closed urinary drainage system thereby enhancing drainage characteristics Vent 610 may be formed fiom a material that is permeable to vapor, but impermeable to liquid, as is known in the art A vent formed from such a material may enhance drainage characteristics of the Foley catheter while preventing any undesirable leakage [0039] FIG. 7 shows a side view of a proximal end of a Foley cathetet implementing a sampling poit 710 and cap 700 according to the disclosure. Cap 700 includes cap poition 702, occlusion lever 704, living hinge 706, and diain tube housing 708. Cap 700 is preferably implemented on sampling poit 710. Port 710 is coupled to (and may, in certain embodiments, fbim pait of) the pioximal end of cathetei 712. Drainage tube housing 708 is shown as engaged to drainage tube 714.

[0040] FIG. 8 shows a top view of a proximal end of a Foley catheter implementing a cap 800 according to the disclosure Cap 800 includes cap poition 802, secondary port 804, and drain tube housing 808. Second port 804 enables conversion of a two-way Foley catheter into a three-way Foley catheter that is capable of receiving infusion,

[0041] Cap 800 is coupled to a sampling port (not visible in FIG 8) which is located on the proximal end of catheter 812. Drainage tube housing 808 is shown as engaged to drainage tube 814.

[0042] FIG. 9 shows a partially sectional side view of a Foley cathetei implementing a sampling port 910 and cap 900 according to the disclosure. Cap 900 includes cap poition 902, occlusion lever 904, living hinge 906, and drain tube housing 908. A semi-sectional portion of catheter 912, which reveals lumen 916 within cathetei 912, is also shown. A drainage tube is shown at 914

[004.3] FIG 9 also shows arc 918 Arc 918 indicates the arcuate path of rotation of cap poition 902 about a pivot point located in, oi proximal to, living hinge 906. When cap portion 902 is flipped open, and is iotated about the pivot point, occlusion lever 904 is forced downwards into drainage tube 914. As such, drainage tube is substantially occluded, and urine collects at the point of port 910. Consequently, urine can then be sampled from sampling port.

[0044] FIG. 9 also shows that on the side of diainage tube housing 908 that extends into the page, drainage tube 914 may be stabilized during an opening of cap portion 902. As such, diainage tube 914 may not be able to move in a direction that extends into the page

[0045] Additionally, one alternative of the disclosure may include an embodiment (see FIG. 11) in which a stabilization bai 1102 may extend from occlusion level 1104 out of the page and down on the exposed side of a drainage tube (not shown in FIG. 11) that is not completely enclosed by drainage tube housing 1108 In such an embodiment, the drainage tube can be substantially completely circumfeientially stabilized in oidei to prevent any slippage dming the occlusion of the tube by occlusion levei 1104

[0046] In yet an additional alternative embodiment, a cap according to the disclosure may be formed from different dimensions than the cap shown in FIGs 5-9 Foi example if there is a gieater distance than shown between the cap portion and the occlusion lever, the levering action, and, consequently, the force exhibited on the diainage tube, may be increased Furthermore, such a placement, which could extend the occlusion levei down the tube a number of inches, allows a greater pool of mine to form which may facilitate sampling of the urine.

[0047] FIG. 10 shows a sectional side view of a Foley cathetei implementing a sampling port 1010, bypass lumen 1012 and cap 1000 according to the invention Port 1010 is shown mounted on mount 1014 which connects between catheter funnel 1016 and diainage tube 1018 Bypass lumen 1012 is adapted to be connected in a selectable connection to sample port connector 1008 Auxiliary sampling port is shown at 1006. Bypass lumen 1012 is in fluid communication with a first fluid pathway configured to connect to a pressure transducer and a second fluid pathway configured to connect to a fluid infusing device, as required for appropriate inter -abdominal pressure testing

[0048] Typically, once sampling port connector 1008 is engaged with sampling port 1010, fluid may flow between the urinary catheter system and the inter -abdominal pressure measurement system When fluid is flowing between lumen 1012 and the catheter, then, in certain embodiments of the disclosure, the flow to auxiliary sampling port 1006 is blocked Conversely, when flow to auxiliary port 1006 exists, fluid flow to lumen 1012 is blocked

[0049] Under certain conditions, lumen 1012 is pinched off (alternatively described herein as occluded), similar to the manner in which the drainage tube in FIGs. 7-9 is pinched off When the cap portion 1002 of cap 1000, which is shown schematically in FIG 10, is opened, occlusion lever 1004, which may be implemented in any number of suitable ways, including but not limited to the way the occlusion lever is implemented in FΪGs 5-9 and 11, pinches off lumen 1012 This mannei of operation allows foi the selecting between one of 1) fluid flow fiom the drainage system to the pressure measurement system and 2) fluid flow fiom the drainage system to auxiliary sampling poit 1006 wheieby when one of these is in fluid connection the other is not

[0050] Fuithei details desciibing the need foi and operation of lumen 1012 are described in PCT Application Publication No WO 2007/018963 which is hereby incorporated by reference herein in its entirety. In the particular embodiment described herein, lumen 1012 is shown as operating through the sample port 1010 of a urine drainage system Nevertheless, it should be understood that other embodiments of the disclosure may implement a sampling port cap for¹ use with sampling a port bypass lumen as used in other alternative implementations

[0051] It should be noted that port 1010, as well as any of the other ports shown or described herein may be mounted on 1) the proximal end of the catheter, 2) a mount, such as mount 1014 that couples a catheter to a drainage tube, such as drainage tube 1018, or 3) a drainage tube All of these locations for mounting of port 1010, or any of the other ports disclosed herein, are within the scope of the disclosure

[0052] FIG 12 shows an embodiment of the disclosure wherein cap 1200 includes cap portion 1202, occlusion lever 1204, a conventional two-piece pinned hinge 1206, and drain tube housing 1208 In this particular case, the living hinge has been replaced by a conventional pinned two-piece hinge Hinge 1206 is shown in greater detail in the accompanying blown-up portion A-A of FIG 1200.

[0053] Thus, systems and methods for reducing patient discomfort, facilitating urine sampling and drainage, and generally enhancing use of the EZ-Lok™ Sampling Port, or other suitable sampling port, are provided

[0054] Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims

Claims

CLAIMS:

1 A medical device that coveis a diainage catheter sampling port, said device comprising: a cap portion, said cap portion covering the catheter sampling poit; an occlusion level rigidly coupled to the cap portion; and a drainage tube housing mechanically coupled to the cap portion and the occlusion lever, the diainage tube housing adapted to be coupled to a diainage tube, wherein when the cap portion is opened, the occlusion lever is adapted to occlude the drainage tube

2 The medical device of claim 1 wheiein the cap portion comprises a vent

3 The medical device of claim 1 further comprising an infusion port foi infusing fluid into the drainage catheter

4. The medical device of claim 1 furthei comprising a bypass lumen configured to piovide fluid communication between the sampling port and a pressure transducer

5 The medical device of claim 1 further comprising a bypass lumen configured to piovide fluid communication between the sampling port and a fluid infusion device

6. Ihe medical device of claim 1 wherein the drainage tube housing is pivotably coupled to the cap portion

7. A medical device that covers a catheter sampling poit, said device compiising: a cap portion, said cap portion covering the catheter sampling port; an occlusion lever rigidly coupled to the cap portion; a living hinge coupled to the cap portion and the occlusion lever; and a drainage tube housing adapted to fixedly attach to a drainage tube, the drainage tube housing mechanically coupled to the living hinge, wherein when the cap poition is opened, the cap moves in a substantially arcuate path with iespect to the living hinge and, responsive theieto, the occlusion level is adapted to occlude the drainage tube

8 The medical device of claim 7 wherein the cap poition comprises a vent

9 The medical device of claim 7 further comprising an infusion port for infusing fluid into the drainage cathetei ,

10 The medical device of claim 7 further comprising a bypass lumen configured to provide fluid communication between the sampling poit and a piessure tiansducei

11 The medical device of claim 7 further comprising a bypass lumen configured to provide fluid communication between the sampling port and a fluid infusion device

12 A method for using a sampling port in a urine drainage system, said method comprising: opening a cap poition of a sampling poit cap, the cap poition covering the sampling port, said cap portion configured to move along a substantially arcuate path with respect to a living hinge pivot point; and in response to the opening of the cap portion, occluding a drainage tube portion of the urine drainage system using an occlusion levei portion of the sampling port cap, the occlusion levei being rigidly coupled to the cap portion such that the cap poition moving along a substantially arcuate path with respect to the pivot point causes the occlusion levei to occlude the diainage tube.

13 The method of claim 12 further comprising venting the cap portion of the sampling poit cap in order to enhance diainage in the urine drainage system

14 The method of claim 12 further comprising infusing liquid into the urine drainage system via an infusing port in the sampling port.

15. The method of claim 12 further comprising measuring intra-abdominal piessure of a patient via a bypass lumen which is in fluid connection with the sampling poit via a sampling poit connector

16. A medical device for measuring intra-abdominal pressure comprising: a bypass lumen; a sampling port connector connect to the bypass lumen and configured to be removably attached to a sampling port of a urinary catheter system to form a fluid connection between the urinary catheter system and the bypass lumen, the sampling port connector further comprising an auxiliary sampling port; an auxiliary sampling port cap comprising: a cap portion, said cap portion that covers the auxiliary sampling poit; and an occlusion lever mechanically coupled to the cap portion, wherein when the cap portion is opened, the occlusion lever occludes the bypass lumen.

17. The medical device of claim 16, the auxiliary sampling port cap further comprising a vent

18. The medical device of claim 16, the sampling port further comprising an infusion port.

19 The medical device of claim 16 further comprising a pressuie transducer in fluid communication with the sampling port via the bypass lumen.

20 The medical device of claim 16 further comprising a fluid infusion device in fluid communication with the sampling port via the bypass lumen .