FIELD OF THE INVENTION

This invention relates generally to medical devices and methods and more particularly to devices and methods for automatically removing urine from a female patient using suction applied to an external catheter.

BACKGROUND OF THE INVENTION

Various external catheters are available for non-invasive urine output management in female patients. The PUREWICK® female external catheter available from C.R. Bard, Inc. is an example of one such device. That external catheter is a soft member having a hollow flexible body including a side opening exposing soft absorbent gauze. The catheter is configured to be positioned so that soft gauze is disposed between the patient's separated gluteus and labia and in fluid communication with the urethral opening of the patient, whereupon urine voided by the patient is wicked into the gauze. The catheter is arranged to be attached via suction tubing to a suction canister, which should in turn be connected to either a suction regulator on a hospital wall or a portable suction pump, such as the DRYDOC™ vacuum suction station of C.R. Bard, Inc., whereupon the urine wicked into the external catheter is carried by the suction into the canister for collection. The Instructions for Use (IFU) of the PUREWICK® female external catheter indicates that the suction source should be set to a minimum of 40 mmHg continuous suction.

Sage Products, LLC, now a Stryker Corporation company, provides an external urine management system for females under the trademark PRIMAFIT. That system is in many respects similar to the PUREWICK® system. In particular, the PRIMAFIT system basically comprises an external catheter body having an end cap to fit in the woman's perineal area to secure the catheter in place. The catheter includes soft wicking fabric that absorbs and diverts urine away from the patient's skin. Urine is then absorbed into the system's core and suctioned into a collection canister.

The patented literature includes various systems and methods for collecting and transporting urine away from a person's body, such as: U.S. Pat. No. 4,610,675 (Triunfol); U.S. Pat. No. 4,747,166 (Kuntz); U.S. Pat. No. 5,678,564 (Lawrence et al.); U.S. Pat. No. 5,894,608 (Birbara); U.S. Pat. No. 6,849,065 (Schmidt et al.); U.S. Pat. No. 7,018,366 (Easter); U.S. Pat. No. 7,220,250 (Suzuki et al.); and U.S. Pat. No. 8,287,508 (Sanchez).

All of the references as cited herein are specifically incorporated by reference

As will be appreciated by those skilled in the art, most hospital suction regulators provide insufficient flow at low vacuum pressures, like the 40 mmHg recommended for use with the PUREWICK® female external catheter. Therefore nurses or other care givers frequently increase the vacuum to get adequate urine flow. However, the use of higher vacuum pressure poses an increased risk to the patient, as the only opening in the circuit for air to relieve the pressure is adjacent the patient's genitalia. Accordingly, use of increased vacuum pressure to increase the flow rate of urine being withdrawn into the canister runs the risk of injury to the delicate issue adjacent the urethral opening.

Thus, a need exists for a system and method which is efficient for removing urine from a patient using an external catheter, wherein the flow rate is sufficiently high for increased effectiveness, yet is produced by a suction level that is sufficiently low to minimize the danger of injury to the delicate tissue of the patient adjacent the patient's urethral opening. The subject system addresses that need by providing a disposable suction regulator configured for use between the female external catheter and a canister coupled to a source of higher suction, e.g., a regulator at the hospital's suction line. To that end the disposable female external catheter suction regulator of this invention is designed in such a way that it allows far greater flow at low pressures than do the traditional wall regulators. As such, it is intended to be placed in the same circuit, but between the external catheter and the canister.

SUMMARY OF THE INVENTION

One aspect of this invention is a system for automatically removing by suction urine voided by a female. The system comprises an external catheter, a receptacle or canister, and a suction regulator. The external catheter is configured for external disposition in fluid communication with a urethra opening of the female, whereupon urine voided by the female is received by the external catheter. The receptacle or canister is configured for collecting urine and also configured to be coupled to a source of suction providing suction having a first value. The suction regulator is interposed between the external catheter and the receptacle to regulate the amount of suction from the first value to a regulated value lower than the first value and to apply regulated suction at the regulated value to the external catheter, whereupon urine from the external catheter is carried through the suction regulator and into the receptacle or canister.

In accordance with one preferred aspect of the system of this invention the receptacle or canister comprises a first port, a second port, and a hollow interior in fluid communication with the first and second ports. The first port is configured to be connected to the source of suction. The suction regulator comprises a first port and a second port. The second port of the suction regulator is configured for coupling to the second port of the receptacle or canister. The suction regulator is configured for providing the regulated suction at the first port thereof. The first port of the suction regulator is configured to be coupled to the external catheter to carry urine from the external catheter by the regulated suction through the suction regulator and into the first port of the receptacle or canister for collection in the hollow interior.

In accordance with another preferred aspect of the system of this invention the regulated value of suction is within the range of approximately 40-175 mmHg.

In accordance with another preferred aspect of the system of this invention the urine is carried through the suction regulator into the receptacle by air which is flowing at a flow rate up to approximately 100 standard cubic feet per hour (SCFH) (which converts to 47 liters per minute (LPM)).

In accordance with another preferred aspect of the system of this invention the regulator is disposable.

In accordance with another preferred aspect of the system of this invention the suction regulator comprises a first chamber, a second chamber, a movable diaphragm and a biasing member. The first chamber is configured to have suction applied thereto from the receptacle or canister. The second chamber is at atmospheric pressure. The movable diaphragm separates the first chamber from the second chamber, whereupon a differential pressure exists between the first and second chambers. The differential pressure imparts a differential pressure force on the movable diaphragm. The biasing member is configured to impart a counter force on the movable diaphragm that opposes the differential pressure force.

In accordance with another preferred aspect of the system of this invention the first chamber comprises a valve seat and a movable sealing member coupled to the movable diaphragm. The valve seat surrounds an opening for fluid within the first chamber to flow therethrough. The sealing member blocks the opening when the differential pressure force exceeds the counter force imparted by the biasing member.

In accordance with another preferred aspect of the system of this invention the suction regulator is configured to prevent the movable sealing member from becoming stuck on the valve seat.

In accordance with another preferred aspect of the system of this invention the suction regulator comprises a bleed hole in the diaphragm to enable ambient air from the second chamber to enter into the first chamber.

In accordance with another preferred aspect of the system of this invention the first and second chambers are located within a housing, and wherein the second chamber includes a bleed hole in the housing in communication with the ambient atmosphere.

In accordance with another preferred aspect of the system of this invention the bleed hole in the housing is located within a recess having at least one opening at an end thereof to prevent blockage of the bleed hole.

In accordance with another preferred aspect of the system of this invention the movable diaphragm has a natural shape, is molded from a flexible material, and does not require eversion for disposition in the suction regulator to separate the first chamber from the second chamber, whereupon the movable diaphragm is less prone to creep over time.

In accordance with another preferred aspect of the system of this invention urine is carried through the suction regulator and into the receptacle or canister by air and wherein the suction regulator comprises a body and a sound suppressor. The body has a first passageway configured to be coupled to the external catheter, a second passageway configured to be coupled to the source of suction, and third passageway connecting the first and second passageways to result in a tortuous fluid flow path through the passageways. The sound suppressor is located in the second passageway for reducing the sound of air flowing through the suction regulator.

In accordance with another preferred aspect of the system of this invention the second passageway is offset from the first passageway and interconnected thereto by a third passageway extending generally perpendicularly to the first and second passageways.

In accordance with another preferred aspect of the system of this invention the sound suppressor comprises a tube having a multitude of small hook-like projections extending generally radially inward.

In accordance with another preferred aspect of the system of this invention the system additionally comprises an adapter configured to be coupled between the source of suction and the receptacle or canister. The adapter comprises an inlet, a valve and a first connector. The inlet is configured to be connected to the source of suction. The first connector is configured to be connected to the receptacle or canister. The valve is configured to be in either a closed state or an open state, whereupon when in the closed state the receptacle or canister is isolated from the inlet, and when in the open state suction at the first value is provided from the inlet to the first connector and to receptacle or canister.

In accordance with another preferred aspect of the system of this invention the adapter includes an internal passageway having one end in communication with the inlet and another end in communication with the first connector, and wherein the valve includes a rotatable portion having an opening extending therethrough. The rotatable portion intersects the internal passageway, whereupon when the rotatable portion is in a first rotatable position the rotatable portion blocks the internal passageway between the inlet and the first connector, and when the rotatable portion is in a second position the opening unblocks the internal passageway between the inlet and the first connector to enable suction at the first value to appear at the first connector.

In accordance with another preferred aspect of the system of this invention the first connector is configured to have a first section of suction tubing having a first end connected to it and a second end connected to the receptacle or canister.

In accordance with another preferred aspect of the system of this invention the first connector is a barbed bubble connector.

In accordance with another preferred aspect of the system of this invention the adapter additionally comprises a splitter including a second connector having a passageway section in fluid communication with the internal passageway between the inlet and the valve, whereupon suction at the first value is available from the inlet to the second connector irrespective of the state of the valve.

In accordance with another preferred aspect of the system of this invention the adapter and splitter includes an internal passageway having one end in communication with the inlet and another end in communication with the first connector, and wherein the valve includes a rotatable portion having an opening extending therethrough. The rotatable portion intersects the internal passageway, whereupon when the rotatable portion is in a first rotatable position the rotatable portion blocks the internal passageway between the inlet and the first connector, and when the rotatable portion is in a second position the opening unblocks the internal passageway between the inlet and the first connector to enable suction at the first value to appear at the first connector.

In accordance with another preferred aspect of the system of this invention the urine is carried through the suction regulator into the receptacle by air flow, wherein a differential pressure between the external catheter and the suction regulator results, and wherein the system is configured so that the differential pressure of no more than approximately 55 mmHg provides an air flow rate of greater than 25 LPM.

In accordance with another preferred aspect of the system of this invention the urine is carried through the suction regulator into the receptacle by air flow, wherein a differential pressure between the external catheter and the suction regulator results, and wherein the system is configured so that the differential pressure of no more than approximately 100 mmHg provides an air flow rate of greater than 35 LPM.

In accordance with another preferred aspect of the system of this invention the urine is carried through the suction regulator into the receptacle by air flow and wherein the rate of the air flow is greater than 45 LPM.

In accordance with another preferred aspect of the system of this invention the urine is carried through the suction regulator into the receptacle by air flow and wherein the system exhibits a ratio the air flow rate in LPM squared to the regulated value is at least 13.

