Product and method to treat female incontinence

• US 5,352,182 A
• Filed: 05/27/1992
• Issued: 10/04/1994
• Est. Priority Date: 05/27/1992
• Status: Expired due to Fees

• Current Assignee: Irvin M. Kalb, Michael J Ram, Robert H. Shaw
• Original Assignee: Irvin M. Kalb, Michael J Ram, Robert H. Shaw
• Inventors: Ram, Michael J., Shaw, Robert H., Kalb, Irvin M.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US07/888,597
• Time in Patent Office: 860 Days
• Field of Search: 604/55, 604/93, 604/96-104, 604/105, 604/106, 604/246, 604/247, 604/329-330, 606/191, 606/192, 606/193, 606/194, 600/29-31
• US Class Current: 600/30
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/201 Assessing renal or kidney functions
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: 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

Abstract

A system for controlling drainage of the female bladder comprising a valved catheter, a stylet for placing the catheter in the female urethra, and a spike for opening the valve in the catheter to allow voiding of the contents of the bladder. The system also includes a sizing device for determining the length of the urethra so that the proper fitting catheter is used. The catheter comprises a hollow shaft with a extendable sealing portion on one end for placement through the urethra and a crown on the other end for placement external of the body. The valve may be integral with the shaft or insertable after the catheter is placed in the urethra.

Claims

1. A urinary drainage catheter for placement in the female urethra, the urethra having an exterior opening at the point of exit from the body and an interior opening at the point of entry into the urinary bladder, 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, 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 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 resting against the interior end of the urethra, and

the cap having a width greater than the outer diameter of the shaft, an upper surface of said cap resting against the exterior opening of the urethra, no portion of the urinary drainage catheter extending exterior of the urethra cap.

2. The urinary drainage catheter of claim 1 further including a valve within the hollow shaft to control flow of fluid through the catheter.

9. The urinary drainage catheter of claim 1 wherein the length of the shaft is from about 2.5 cm to about 4.5 cm.

10. The urinary drainage catheter of claim 1 wherein the diameter of the cap and the crown is from about 12 mm to about 17 mm.

11. The urinary drainage catheter of claim 1 wherein the width of the sealing portion can be temporarily reduced to a width approximately the outer diameter of the shaft for passage of the sealing portion readily through the urethra.

12. The urinary drainage catheter of claim 1 where the sealing portion has a crown spaced from the shaft and wherein the width of the sealing portion is reduced to about the outer diameter of the shaft by passing a stylet through the hollow shaft into contact with the crown and moving the crown longitudinally away from the shaft by advancing the stylet further along the length of the shaft.

13. The urinary drainage catheter of claim 2 wherein the valve is openable by inserting a spike having a central lumen through the cap and into contact with a resealable portion of the valve.

14. The urinary drainage catheter of claim 13 wherein the valve is a duck bill valve and the spike opens the valve by passing through the center of the valve allowing urine to flow through the lumen in the spike.

15. The urinary drainage catheter of claim 13 wherein the spike depresses the sealing portion of a spring loaded valve allowing urine to pass through the valve and the lumen in the spike.

16. The urinary drainage catheter of claim 1 wherein urine flow is controlled by a plug inserted into a drainage opening in the cap.

17. The urinary drainage catheter of claim 1 wherein the cap is adapted to receive a valve mechanism which is inserted therein after placement of the catheter in the female urethra.

3. A urinary drainage control system comprising a valved urinary drainage catheter for placement in the female urethra, the urethra having an exterior opening at the point of exit from the body and an interior opening at the point of entry into the urinary bladder, a stylet for use in placing the catheter, and a hollow spike for opening the valve to allow drainage of fluid from the bladder,

the 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 drainage catheter extending exterior of the urethra beyond the cap, and a valve located within the lumen of the shaft, 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 fluid 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 has a hole therethrough in line with the lumen through the shaft and a width greater than the outer diameter of the shaft,

the stylet is a stiff rod with a diameter less than the inner diameter of the shaft and a length greater than the length of the catheter such that insertion of the stylet through the lumen of the catheter and pushing the stylet against the sealing portion causes the sealing portion to elongate and the width to reduce to a diameter suitable for passing through the urethra,

the spike having an insertion portion, an exterior portion, a flange on an outer surface thereof separating the insertion portion from the exterior portion, a diameter approximating the inner diameter of the shaft and a length sufficient to enter the valve, the exterior portion of the spike being sized for grasping in the fingers of a user such that when the insertion portion is passed through the hole in the cap and the flange is in contact with the cap the valve opens allowing fluid to drain from the bladder through the shaft, valve and the lumen of the spike without soiling the fingers of the user.

4. A female urethra sizing device comprising a hollow shaft, a sealing portion on a first end of the shaft, a removable disk on a second end of the shaft, and indicia on the outer surface of the shaft, wherein:

the shaft has a length longer than the length of the urethra being measured and an outer diameter approximating the diameter of the urethra, the indicia being located at least on the shaft surface which extends from the urethra when the sealing means is placed in the bladder and against the urethral opening into the bladder,

the sealing portion has a width greater than the diameter of the shaft, the width of the sealing portion being reducible so that the sealing portion can be readily passed through the urethra, and

the disk is slidable over the shaft outer surface into contact with exterior opening of the urethra after the shaft is placed in the urethra with the sealing means in the bladder, the indicia being observable after the disk is so positioned.

5. The process of placing a fluid drainage control catheter in the female urethra comprising:

determining the diameter and length of the female urethra,

placing a catheter in the urethra, the catheter comprising;

a hollow shaft of an outer diameter approximating the diameter of the urethra, the shaft having a sealing portion on a first end and a cap on a second end, the distance between a lower surface of the sealing portion and an upper surface of the cap approximating the determined length of the urethra and a valve portion located between the first end and the second end,

the placement procedure comprising;

inserting a stylet through a hole in the cap and along the length of the lumen in the shaft into contact with an inner surface on the sealing portion,

further inserting the stylet along the length of the lumen causing the inner surface of the sealing portion to be temporarily distended from the juncture of the sealing portion with the shaft and temporarily reducing the outer diameter of the sealing portion to a diameter approximating the diameter of the urethra,

inserting the distended sealing portion followed by the shaft into the external opening of the urethra and along the length of the urethra until the sealing portion is in the bladder and the cap rests against the exterior opening of the urethra, and

removing the stylet from the catheter allowing the sealing portion to resume its original configuration.

6. The process of claim 5 wherein the valve portion of the catheter includes an integral valve located in the lumen of the shaft, the valve being formed so that the stylet can be inserted along the shaft without damaging the valve.

7. The process of claim 5 further including the insertion of a valve into the valve portion of the shaft lumen after removal of the stylet.

8. The process of draining the bladder of a female after insertion of a valved drainage catheter into the female urethra, the catheter comprising a hollow shaft with an inner diameter and an outer diameter, the shaft having a sealing portion on a first end, the sealing portion being located in the female bladder, a cap on a second end of the shaft, the cap being located at the exterior end of the female urethra, and a valve located in the shaft between the sealing portion and the cap, drainage being accomplished by the use of a hollow spike having an insertion portion and an exterior portion, the process comprising:

placing the insertion portion of the hollow spike through an opening in the cap and partially along the length of the hollow shaft into contact with the valve, so that the contact of the spike with the valve causes the valve to open, allowing drainage of fluid from the bladder, through the hollow shaft, the valve and the hollow spike, the insertion portion of the spike having an effective length sufficient only to open the valve and an outer diameter which restricts flow of fluid between the spike outer surface and the shaft inner diameter, the length of the exterior portion of the spike being sufficient for grasping by a user during the drainage procedure, drainage being accomplished without soiling the hands of the user.