# US 5,704,353 A · Urinary diagnostic catheter

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- Number: US 5,704,353 A
- Document ID: US5704353A
- Status: Granted
- Kind: A
- Application number: 08/573,184
- Filed: 1995-12-15
- Granted: 1998-01-06
- Earliest claimed: 1992-05-27
- Inventors: Irvin M. Kalb; Robert H. Shaw; Michael J. Ram
- Web page: https://patentgrep.com/patent/US5704353A

## CPC

- A61B 5/14539: {for measuring pH}
- A61B 5/14507: {specially adapted for measuring characteristics of body fluids other than blood (devices for taking samples of body liquids A61B10/0045)}
- A61B 5/20: for measuring urological functions {restricted to the evaluation of the urinary system (A61B5/4375 takes precedence)}
- A61B 5/201: {Assessing renal or kidney functions}
- A61B 5/202: {Assessing bladder functions, e.g. incontinence assessment}
- A61B 5/205: {Determining bladder or urethral pressure}
- A61F 2/0009: {placed in or outside the body opening close to the surface of the body (plugging an opening in the wall of a hollow or tubular organ A61B17/0057)}
- A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections}
- A61M 2205/3324: PH measuring means
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61M 2205/3368: Temperature
- Y10S 128/903: Radio telemetry
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

A system for monitoring the physical and chemical properties of urine in the urinary bladder and functioning of the bladder. For example, the system can include sensors for pressure, temperature, pH, various different chemical constituents of urine, sodium, potassium, glucose, drug markers, drug metabolites, specific gravity, proteins, leukocyte esterase, nitrites, urobilinogen, whole or crenated blood cells, ketones, bilirubin, turbidity or color, the sensors being connected to transmission means for delivering signals representative of the properties detected by the sensors.

## Claims

### Claim 1

A urinary catheter for placement in a urethra in a human body, said urethra having a measurable diameter, an exterior opening at a point of exit from the human body and an interior opening at a point of entry into a urinary bladder within the human body and a length extending from said exterior opening to said interior opening, the catheter comprising a hollow shaft, a sealing portion on a first end of the shaft and a cap on a second end of the shaft, and sensors mounted therein, wherein:
the hollow shaft has a length sized to approximate the length of the urethra and an outer diameter approximating the diameter of the urethra such that the shaft does not extend beyond the exterior opening of the urethra,
the sealing portion having
a) an upper surface with openings therein so that fluid in the bladder can enter the shaft, and
b) a width greater than the outer diameter of the shaft, the width of the sealing portion being reducible so that the sealing portion can be readily passed through the urethra,
a lower surface of said sealing portion adapted to rest against the interior of the urethra, and
the cap having a width greater than the outer diameter of the shaft, an upper surface of said cap adapted to rest against the exterior opening of the urethra, no portion of the urinary catheter extending exterior of the urethra past the cap,
said sensors capable of qualitatively or quantitatively sensing properties of fluid in the bladder, said properties selected from the group consisting of pressure, pH, temperature, various different chemical constituents of urine, sodium, potassium, glucose, drug markers, drug metabolites, specific gravity, proteins, leukocyte esterase, nitrites, urobilinogen, whole blood crenated blood cells, ketones, bilirubin, turbidity and color, the sensors being connected to transmission means for delivering signals representative of the properties detected by the sensors.

### Claim 2 (depends on 1)

The urinary catheter of claim 1 wherein said properties of the urine are detected by optical means, said optical means comprising at least a first and a second fiber optic lead terminating in a portion of the urinary catheter within the bladder and in contact with the urine, the leads being positioned to transmit a light beam through the urine such that the light beam exiting the first fiber optic lead is received by the second fiber optic lead, the properties of the light received by the second lead being optically analyzed to determine properties of the urine.

### Claim 3

A bladder monitoring system comprising a urinary catheter for placement in a urethra in a human body, said urethra having an exterior opening at a point of exit from the human body and an interior opening at a point of entry into a urinary bladder within the human body, and a length extending from said exterior opening to said interior opening, a stylet for use in placing the urinary catheter, and sensors to monitor physical and chemical properties of urine within the urinary bladder,
the urinary catheter comprising a hollow shaft with a lumen longitudinally through its center, a sealing portion on a first end of the shaft, a cap on a second end of the shaft, no portion of the urinary catheter extending exterior of the urethra beyond the cap, and sensors mounted on the catheter adapted to be in contact with the urine within the urinary bladder, wherein:
the shaft has a length sized to approximate the length of the urethra and an outer diameter approximating the diameter of the urethra such that the second end of the shaft is adapted to be located at the exterior opening of the urethra,
the sealing portion has a width greater than the outer diameter of the shaft, there being openings through the sealing portion so that urine in the bladder can enter the shaft lumen, the width of the sealing portion being reducible so that the sealing portion can be readily passed through the urethra,
the cap having a width greater than the outer diameter of the shaft, and
the stylet is a stiff rod with a diameter less than the diameter of the lumen of the shaft and a length greater than the length of the catheter such that insertion of the stylet through the lumen of the urinary catheter and pushing the stylet against the sealing portion causes the sealing portion to elongate and the width of the sealing portion to reduce to a diameter suitable for passing through the urethra,
and wherein the sensors are selected from the group consisting of devices capable of qualitatively or quantitatively sensing pressure, pH, temperature, various different chemical constituents of urine, sodium, potassium, glucose, drug markers, drug metabolites, specific gravity, proteins, leukocyte esterase, nitrites, urobilinogen, whole and crenated blood cells, ketones, bilirubin, turbidity and color.

### Claim 4 (depends on 3)

The bladder monitoring system of claim 3 further including a signal transmitter and signal transmission means connecting the sensors with the signal transmitter, the signal transmitter capable of delivering information obtained by the sensors to a remote location.

### Claim 5 (depends on 4)

The bladder monitoring system of claim 4 further including a power source for supplying energy to the signal transmitter.

### Claim 6 (depends on 5)

The bladder monitoring system of claim 5 wherein the power source comprises a positive and negative electrode located within a space enclosed by the catheter, the positive and negative electrode in contact with the urine, the urine being an electrolyte, the positive electrode, negative electrode and urine comprising a battery.

### Claim 7 (depends on 3)

The urinary catheter of claim 3 wherein said chemical properties of the urine are detected by optical means, said optical means comprising at least a first and a second fiber optic lead terminating in a portion of the urinary catheter adapted to be within the bladder and in contact with the urine, the leads being positioned to transmit a light beam through the urine such that the light beam exiting the first fiber optic lead is received by the second fiber optic lead, the properties of the light received by the second lead being optically analyzed to determine properties of the urine.

### Claim 8

A bladder monitoring system placeable into a urinary bladder in a human body via the urethra, said system including sensors to monitor physical and chemical properties of urine, and including means to retain the sensors within the urinary bladder wherein the sensors are selected from the group consisting of devices capable of qualitatively or quantitatively sensing pressure, pH, temperature, various different chemical constituents of urine, sodium, potassium, glucose, drug markers, drug metabolites, specific gravity, proteins, leukocyte esterase, nitrites, urobilinogen, whole or crenated blood cells, ketones, bilirubin, turbidity and color.

### Claim 9 (depends on 8)

The bladder monitoring system of claim 8 further including a signal transmitter and signal transmission means connecting the sensors with the signal transmitter, the signal transmitter capable of delivering information obtained by the sensors to a remote location.

### Claim 10 (depends on 9)

The bladder monitoring system of claim 9 further including a power source for supplying energy to the signal transmitter.

### Claim 11 (depends on 10)

The bladder monitoring system of claim 10 wherein the power source comprises a positive and negative electrode adapted to be in contact with the urine, the urine being an electrolyte, the positive electrode, negative electrode and urine comprising a battery.

### Claim 12 (depends on 8)

The urinary catheter of claim 8 wherein chemical properties of the urine are detected by optical means, said optical means comprising at least a first and a second fiber optic lead terminating in a portion of the urinary catheter within the bladder and in contact with the urine, the leads being positioned to transmit a light beam through the urine such that the light beam exiting the first fiber optic lead is received by the second fiber optic lead, the properties of the light received by the second lead being optically analyzed to determine properties of the urine.

### Claim 13

A bladder monitoring system comprising a urinary catheter for placement in a urethra in a human body, said urethra having an exterior opening at a point of exit from the human body and an interior opening at a point of entry into a urinary bladder within the human body, and a length extending from said exterior opening to said interior opening, a stylet for use in placing the urinary catheter, and sensors to monitor physical and chemical properties of urine within the urinary bladder,
the urinary catheter comprising a hollow shaft with a lumen longitudinally through its center, a sealing portion on a first end of the shaft, a cap on a second end of the shaft, no portion of the urinary catheter extending exterior of the urethra beyond the cap, and sensors mounted on the catheter in contact with the urine within the urinary bladder, wherein:
the shaft has a length sized to approximate the length of the urethra and an outer diameter approximating the diameter of the urethra such that the second end of the shaft is located at the exterior opening of the urethra,
the sealing portion has a width greater than the outer diameter of the shaft, there being openings through the sealing portion so that urine in the bladder can enter the shaft lumen, the width of the sealing portion being reducible so that the sealing portion can be readily passed through the urethra,
the cap having a width greater than the outer diameter of the shaft, and
the stylet is a stiff rod with a diameter less than the diameter of the lumen of the shaft and a length greater than the length of the catheter such that insertion of the stylet through the lumen of the urinary catheter and pushing the stylet against the sealing portion causes the sealing portion to elongate and the width of the sealing portion to reduce to a diameter suitable for passing through the urethra,
and wherein the sensors are selected from the group consisting of devices capable of qualitatively or quantitatively sensing pressure, pH, temperature, various different chemical constituents of urine, sodium, potassium, glucose, drug markers, drug metabolites, specific gravity, proteins, leukocyte esterase, nitrites, urobilinogen, whole blood crenated blood cells, ketones, bilirubin, turbidity and color,
the bladder monitoring system further including a signal transmitter and signal transmission means connecting the sensors with the signal transmitter, the signal transmitter capable of delivering information obtained by the sensors to a remote location, and
a power source for supply energy to the signal transmitter, the power source comprising a positive and negative electrode located within a space enclosed by the catheter, the positive and negative electrode in contact with the urine, the urine being an electrolyte, the positive electrode, negative electrode and urine comprising a battery.

### Claim 14 (depends on 13)

The urinary catheter of claim 13 wherein said chemical properties of the urine are detected by optical means, said optical means comprising at least a first and a second fiber optic lead terminating in a portion of the urinary catheter within the bladder and in contact with the urine, the leads being positioned to transmit a light beam through the urine such that the light beam exiting the first fiber optic lead is received by the second fiber optic lead, the properties of the light received by the second lead being optically analyzed to determine properties of the urine.

### Claim 15

A bladder monitoring system placeable into a urinary bladder in a human body via the urethra, said system including sensors to monitor physical and chemical properties of urine, and including means to retain the sensors within the urinary bladder wherein the sensors are selected from the group consisting of devices capable of qualitatively or quantitatively sensing pressure, pH, temperature, various different chemical constituents of urine, sodium, potassium, glucose, drug markers, drug metabolites, specific gravity, proteins, leukocyte esterase, nitrites, urobilinogen, whole or crenated blood cells, ketones, bilirubin, turbidity and color,
said bladder monitoring system further including a signal transmitter and signal transmission means connecting the sensors with the signal transmitter, the signal transmitter capable of delivering information obtained by the sensor to a remote location, and
a power source for supplying energy to the signal transmitter, the power source comprising a positive and negative electrode in contact with the urine, the urine being an electrolyte, the positive electrode, negative electrode and urine comprising a battery.

### Claim 16 (depends on 15)

The urinary catheter of claim 15 wherein chemical properties of the urine are detected by optical means, said optical means comprising at least a first and a second fiber optic lead terminating in a portion of the urinary catheter within the bladder and in contact with the urine, the leads being positioned to transmit a light beam through the urine such that the light beam exiting the first fiber optic lead is received by the second fiber optic lead, the properties of the light received by the second lead being optically analyzed to determine properties of the urine.